Director, Quality Systems Resume Sample

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Garnett Hegmann
33483 Sadye Meadow,  Houston, TX
+1 (555) 275 9019

Work Experience

Director, Quality Systems
02/2016 - PRESENT
Houston, TX
  • Provide leadership for the Quality function through development and implementation of the Quality Management System. Develop, implement and monitor specific strategic quality objectives in alignment with business organization objectives
  • Provide leadership for the development and implementation of ARUP’s document management system including Policies, Processes, and Procedures (SOPs). Provide oversight and monitoring of the document review and approval process
  • Assist various departments, including Medical Directorship, Research & Development, and Technical Operations to define and implement a structured assay/product development and validation process consistent with the strategic direction of the business and regulatory requirements
  • Work in collaboration with all ARUP departments to ensure the highest possible levels of commitment to SOPs and applicable guidance and regulations through the following activities
  • Responsible for leading, managing, and directing assigned operations function which provide support to Operations executing GMP activities
  • Ensures that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations and specifications
  • Develops, implements, and oversees required programs to support cGMP activities
Associate Director, Quality Systems
04/2012 - 01/2016
Detroit, MI
  • Ensures that procedures are in place for cGMP activities, and procedures are followed by area staff
  • Ensures that GMP tasks are complete, accurate, and documented according to written procedures and Good Manufacturing Practices (cGMP) requirements
  • Responsible for selecting and on-boarding staff in accordance with cGMP procedures and requirements
  • Ensures staff are trained and managed according to cGMP procedures and requirements
  • Ensures that area staff are qualified for assigned roles, and trained to perform assigned tasks
  • Supports the implementation, monitoring, performance and maintenance of the Quality Management System
  • Alerts senior management of significant quality, compliance, supply and safety risks
Senior Director Quality Systems
08/2009 - 12/2011
Phoenix, AZ
  • Develop, implement, communicate, and maintain quality control (QC) and quality monitoring programs according to standards of ACMG and CAP
  • Define and maintain QC/QMP objectives, targets, processes and review new targets, plans, and protocols for maintenance of the QCP as needed
  • Establish and maintain QC/QMP documentation procedures as needed
  • Maintain, develop, and coordinate document control processes
  • Perform regular internal quality audits in all laboratories; follow up with recommendations, corrective, and preventive actions as needed
  • Assure proper qualification of laboratory personnel according to CLIA, CAP, and NYS standards
  • Assure proper maintenance and calibration of laboratory equipment


Brown University
2003 - 2008
Bachelor's Degree in Engineering

Professional Skills

  • Leadership and Team Development - Is seen as a leader of the Enterprise and not just function. Watches and seeks leaders from across the Enterprise and actively seeks opportunities for the team within the Enterprise
  • Enterprise Results and Value Orientation - Looks for outcomes that maximize the benefits for the Enterprise not just their department or function and pursues value realization for the Enterprise even if their function does not benefit
  • Customer Orientation (external/internal) - Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs. Drives alignment across the Enterprise to customer needs
  • Collaboration & Influencing - Collaborates effectively with others and influences all stakeholders towards Enterprise outcomes, embracing the sometimes difficult conversations needed to deliver Enterprise value
  • Strategic/Innovative – Exhibits global perspective. Takes a broad view when approaching issues. Sees ahead to future possibilities & translates to breakthrough strategies. Collaborates to influence strategies of others, and adapts own strategy towards Enterprise Value
  • Change Agent - Mobilizes others to initiate change; builds group momentum for change; embeds culture of change. Aligns change to Enterprise strategies and direction
  • Demonstrated strong interpersonal skills and a passion for developing teams and people to their highest potential is required

How to write Director, Quality Systems Resume

Director, Quality Systems role is responsible for negotiation, integration, training, recruiting, auditing, reporting, manufacturing, design, research, travel.
To write great resume for director, quality systems job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Director, Quality Systems Resume

The section contact information is important in your director, quality systems resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Director, Quality Systems Resume

The section work experience is an essential part of your director, quality systems resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous director, quality systems responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular director, quality systems position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Director, Quality Systems resume experience can include:

  • Effective financial management, planning, and organizational skills
  • Excellent leadership, decision-making and analytical skills
  • Effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes
  • Excellent communication, computer and writing skills
  • Strong interpersonal skills with the ability to engage others and gain their buy-in on issues or in situations where there is no direct line of authority
  • Strong people management skills and ability to assess performance of direct reports

Education on a Director, Quality Systems Resume

Make sure to make education a priority on your director, quality systems resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your director, quality systems experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Director, Quality Systems Resume

When listing skills on your director, quality systems resume, remember always to be honest about your level of ability. Include the Skills section after experience. Present the most important skills in your resume, there's a list of typical director, quality systems skills:

  • Proactive in identifying opportunities to streamline operations along with strong problem solving and negotiation skills
  • Understanding of regulatory requirements for validated systems for clinical trials and companion diagnostics
  • Experience owning, tracking, and reporting on a department budget
  • Demonstrated knowledge of plant quality systems, plant data systems, preparing responses to audit observations and deviations, and corporate metric systems
  • Experience managing RA/QA associates
  • Stooping: Bending body downward and forward by bending spine at the waist

List of Typical Experience For a Director, Quality Systems Resume


Experience For Associate Director, Quality Systems Resume

  • Experience in pharmaceutical or bio-pharmaceutical field
  • Quality systems demonstrated knowledge in areas such as quality risk management and management review
  • Ensure oversight and effectiveness of the Quality System across all sites
  • Working knowledge of: FDA regulations, ISO, IVD, EXCiPACT requirements amongst others
  • Establish guidelines and procedures for ISI Learning Management System to develop and deploy general QS training
  • Conduct QC/QA processes of incoming finished packaging

Experience For Director Quality Systems Resume

  • Act as SME and provide training/consultation to internal customers on applicable regulatory requirements (proactively and reactively)
  • The Director of Corporate Quality Systems plays a key leadership role in driving the BSC Quality Culture
  • Manager Enterprise Learning Management
  • Assist in the maintenance of accreditation, permits and licenses in regard to inspections and communication
  • Represent NBO on cross-functional teams involved in the design and implementation of new or updated quality systems in accordance with the, corporate standards, regulatory standards, CGMP and industry standards
  • Areas of responsibility include: Risk management, Standard lifestyle management, Track, trend and statistical analysis, Periodic Product Review (PPR), Deviations, CAPA, Change control and complaints
  • Packaging and labeling and Quality Control oversight
  • Ensure appropriately trained resources are available

Experience For Senior Director Quality Systems Resume

  • Ensure Compliance alignment versus external audits of other Genzyme network site
  • Proactive compliance gap analysis of quality systems
  • Novel and creative development of compliance readiness strategies and improvement programs based on findings of gap analysis, internal/external audits, industry trends and CAPA trend analysis
  • Monitor quality system activities to assure compliance with company and regulatory standards
  • Genzyme standards implemented and updated as necessary

Experience For Associate Director Quality Systems Resume

  • Leads and ensures compliance with cGMP’s, DEA and OSHA regulations on the production shifts
  • Implement and maintain systems, programs and processes to ensure compliance with GMP Quality functions through Phase 1/2 clinical manufacture at Stemcentrx’ internal manufacturing plant
  • Strengthen quality assurance’s infrastructure through education, training, performance based appraisals, and recruiting
  • Provide CSV support during regulatory inspections and be able to articulate Ironwood’s application of Regulatory and Industry standards to its System Development Lifecycle (SDLC)
  • Functions as the Deputy Management Representative for the quality management system
  • Manages and coordinates the Quality Systems staff who exercise responsibility for results in terms of compliance, costs, methods, and employees
  • Establishes and delegates operational goals, objectives and assignments. Formulates and implements policies and procedures to carry out quality policy in support of the BDX policy on a worldwide basis
  • Develops and implements quality information reporting systems and administers FDA, ISO 13485, MDR, and Japanese PAL standards including audits, certification and the Management Review process
  • Effective communication skills at all levels both written and verbal

Experience For Director, Quality Systems Compliance Resume

  • Able to work effectively with autonomy
  • Promotes, develops and manages continuous quality improvement activities through effective utilization of the CAPA system
  • Hosts external regulatory inspections. Ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management
  • Demonstrated ability to motivate and manage exempt and non-exempt level Quality Systems personnel
  • Perform multiple tasks and prioritize work load
  • Strong knowledge of GMP, SOPs and quality system processes and statistical analysis
  • Develops and monitors budgets for capital expenditures, operating supplies, and labor. Provides justification for resource requirements to senior management
  • Communicates project status, compliance progress, problems, and procedures across all applicable groups
  • Carries out Human Resource management responsibilities such as hires, job assignments, coaching, termination recommendations, transfers, promotions, salary actions, and processes performance reviews on time

Experience For Director, Quality Systems Document Control Resume

  • Exercises responsibility for associate training, development, and motivating supervised associates
  • Develops and provides quality system training for the organization WW
  • Partners with other quality professionals to address recurring issues identified throughout the organization
  • Develops, documents, administers, and maintains Quality Systems for conformance to regulatory requirements and company policies
  • Champions systems and processes related to Quality (e.g. SAP, DMS, Change Control). Responsible to perform process standardization between DC sites
  • Thorough knowledge of quality systems regulations. (ISO; FDA)
  • Work in or direct teams to obtain results
  • Organize and supervise people and activities

Experience For Director, Quality Systems & Compliance Resume

  • As a Certified PCQI, oversee and continuously improve QFS programs, SOP’s and training materials to ensure compliance with FSMA, FSVP, HACCP, USDA, Preventive Controls, Food Defense, etc
  • Proficient in MS Word, Excel, Power Point, Visio, Project, statistical software, and other applications
  • Provide leadership and act as primary liaison to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate global business growth
  • Responsible for establishing and maintaining the global compliance program to ensure compliance with global regulatory requirements, international standards, company policies and procedures
  • Establish and maintain programs that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards

Experience For WW Director, Quality Systems Resume

  • Establish and oversee the Quality Systems improvement strategy that includes responsibilities for development, implementation and the continuous improvement of the ISI quality system that is agile and scalable
  • Provide Analysis of quality data to support Regulatory Compliance activities including quarterly Quality Review Board Meetings, responses to agency requests for information and analyses to support quality improvement projects
  • Partner across the company to drive standardization of Quality Systems. Establish the Quality Planning and Quality Objectives process ensuring an effective monitoring and escalation process. Establish programs to effectively monitor and assess the global quality system through metrics and scorecards
  • Facilitate data input into the Management Review process that assures linkage of all ISI sites and provides reviews and visibility to Senior Management. Ensure timely identification and escalation of emerging issues resulting from Management Review and Quality System review
  • Manage stability testing of finished product to confirm expiration date
  • Responsible for management of regulatory inspections (internal and external) and related compliance activities
  • 4) Leads the Global Quality Systems program
  • To migrate CSL to Globally standardized business processes and systems, including Validation, LIMS, Document Management, Change Control, PTCs, and Enterprise Learning Management

Experience For Director, Quality Systems Resume

  • To maintain a comprehensive suite of Global Quality Policies and Procedures to support the harmonized processes and systems
  • To establish appropriate mechanisms and reviews to ensure that harmonized systems are maintained
  • To establish a process for executing changes to globally harmonized Quality systems in a streamlined, timely and efficient manner, free from unnecessary roadblocks
  • 6) Collaborates with R&D, Manufacturing Sites, Pharmacovigilance, GRA and other key stakeholders to coordinate the development of global product lifecycle quality systems in accordance with ICH Q10 Pharmaceutical Quality Systems guidance documents
  • 10) Collaborates with BT Quality to assure alignment regarding Quality Assurance review and system validation and requalification approaches
  • 7) Responsible for support of new site integration into the CSL Behring business
  • 8) Responsible for benchmarking CSL Behring against global pharmaceutical companies in relation to GxP operations and identification of Best Practice opportunities for the organization. This includes the development of Best Practice proposals, generation and implementation of project plans
  • 9) Oversees development and reporting of Global Quality KPIs
  • Manage contract manufacturing processes and contract manufacturer’s QC/QA operations for GMP compliance

Experience For Associate Director, Quality Systems Resume

  • 11) This role requires approximately 20% local and overseas travel
  • Review documents relevant to GMP’s, finished product specifications regarding physical, chemical, and bacteriological characteristics (i.e. finished product certificate of analyses)
  • Issue product recalls and market withdrawals; maintain tracking system for product recall and market withdrawal inventory and final disposition of affected product
  • Manage the product testing program and reporting capabilities of newly approved contract manufacturers or established vendors providing a new product
  • Oversee QC/QA Supervisor and Technician with respect to sampling, auditing, and review of relevant documentation to assure compliance with Standard Operating Procedures

List of Typical Skills For a Director, Quality Systems Resume


Skills For Associate Director, Quality Systems Resume

  • Excellent communication skills, both written and oral,
  • Good negotiation skills with customer-oriented attitude
  • Strong organizational and leadership skills to influence change in a collaborative manner
  • Effectively interact with Manufacturing, Packaging, Product Development, and Customer Service
  • Demonstrate a strong “business partner” approach and attitude providing creative and innovative solutions that meet quality standards
  • Communicate: Frequently and effectively communicates with others
  • Exceptional Leadership skills for the ability to lead teams of a cross-functional and multi-level nature, including senior management representatives
  • Hand on validation (e.g. process, design, software) experience
  • Execellent communcation and supervisory skills

Skills For Director Quality Systems Resume

  • Demonstrated strong understanding of global regulations (US, EU, Canada, JP, Australia)
  • Comprehensive Lean Six Sigma and Project Management skills
  • Effectively manage conflict
  • Ite based experience (Manufacturing, Process Development, or Quality Assurance) in the pharmaceutical/biotech industry
  • In a technical role in technical operations, quality engineering, validation, quality assurance or quality systems

Skills For Senior Director Quality Systems Resume

  • Experience in leading sites/organizations through FDA, Notified Body and other International Reg Agency Audits
  • Strong knowledge of appropriate state, Federal and international regulations impacting the company
  • Proven history in managing diverse teams
  • Experience in working collaboratively with industry and regulatory partners is essential
  • Compliance on the floor efforts which consistently demonstrate self-starting, initiative and engagement
  • Experience with Process Simulations for Aseptic Liquid Filling
  • Experience with paper document based and electronic Quality Management Systems (e-QMS)

Skills For Associate Director Quality Systems Resume

  • Experience in analytical methods of vitamins, minerals, botanicals, and other supplement ingredients
  • Experience demonstrating initiative and attention to detail
  • Strong knowledge of clinical development areas and processes within Merck
  • Four years clinical laboratory or quality compliance experience
  • Management and leadership experience
  • Keep abreast of validated analytical methods, and those in development
  • Prioritize the department’s work and ensure deadlines are met

Skills For Director, Quality Systems Compliance Resume

  • Experience in the medical device industry
  • Continuing Education: Continual assessment of current literature and best practices
  • Working knowledge of quality systems and FDA and EU regulatory requirements
  • Working knowledge of cGMP’s and regulations applicable to the FDA and comparable international regulatory agencies
  • Training Compliance / Quality Training: identify relevant Quality related training needs and facilitate delivery of training enterprise wide
  • Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling

Skills For Director, Quality Systems Document Control Resume

  • Maintain reporting system of analytical testing of finished product according to DSHEA/GMP
  • Key leadership role in representing BSC interests externally (including with industry working groups such as AAMI, Advamed, MDIC)
  • Proficient in drafting and completing highly technical documents and presentations
  • Provide Quality support during Process Simulations for Aseptic Liquid Filling (vial and syringe)
  • Responsibility for the BSC Quality System Management Controls Process, including the coordination of Management Review and Quality Planning
  • Knowledge of GMP for dietary supplments accfording to FDA

Skills For Director, Quality Systems & Compliance Resume

  • Knowledge of aseptic processing and regulatory and industry guidelines and requirements. Ability to train and advise QA professionals and production personnel
  • Provide guidance to staff for the evaluation of existing deviation, CAPA and complaint systems on the global and local level
  • Serve as the leader of Quality Systems at DVC, responsible for oversight of activities requiring cGMP, GLP, or GCP compliance
  • Participates as a member of various ARUP committees, including the Policy & Procedure Committee and the Corporate Compliance Committee
  • Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance
  • Plan, monitor, and control a set of projects, ensuring efficient utilization of resources to achieve program objectives
  • Oversee clear and concise technical writing of SOP’s, Process Flows, Specifications and Programs
  • 5) Manages all aspects of the teams’ financial responsibilities including annual budget development and forecast reviews

Skills For WW Director, Quality Systems Resume

  • Engage with sales and marketing leaders to convey current and future customer requirements
  • Oversight of Global Regulatory Compliance (GRC) Internal Auditing Team
  • Communicate clearly, accurately and directly – both verbally and in writing – to a widely varied audience
  • Knowledge of regulatory aspects of dietary supplements; i.e DSHEA, third party literture, FDAMA, NLEA
  • Investigate, audit, analyze, propose improvements and direct the assigned Quality Management System activities

Skills For Director, Quality Systems Resume

  • Assist to establish, organize, monitor, & obtain agreement on the annual QAD / CQO Staff Quality Management System (QMS) & Product Quality Assessment Program in coordination with QAD / CQO Staff in Japan, as well as Quality Management staff at various Terumo facilities
  • Provide Quality Management System (QMS) assistance for Terumo facilities including
  • Assist to direct & conduct Product Quality / Shoki-Ryudo & QMS assessments of Terumo facilities that manufacture products distributed in the US
  • Manage overall Programs related to complaint handling and CAPA subsystems (e.g. nonconforming product, NCR, CAPA, Quality Investigation Reports (QIR)) while maintaining compliance with Company QMS and applicable regulatory requirements. Activities include
  • Manage and lead staff, as well as, manage the requirements of the function itself
  • Knowledge of cGMPs, cGDPs, as well as, sound quality and regulatory principles consistent with ‘best practices.&#8217
  • Provide management and leadership for the Deviation Management group
  • Ensure compliance with all global and regulatory standards
  • Develop and report to senior site leadership data analysis and metrics to ensure quality of the Deviation Management, CAPA, and Complaint System programs

Skills For Associate Director, Quality Systems Resume

  • Develop and action metrics for tracking and monitoring Quality Management Systems under area of responsibility. Perform quality checks to ensure accuracy, completeness and proper usage of data
  • Prepare and/or review activity, progress, and performance metrics reports
  • Serve as a sub-system owner for the Durham site for the Deviation Management System, CAPA Management System and the Compliant Management System
  • Serve as a member of the DVC Senior Management team with the ultimate responsibility of ensuring that an effective quality system is in place to achieve the quality objectives, and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the company
  • Serve as the organization’s quality advocate by demonstrating strong support for quality initiatives through establishing and communicating the philosophical importance of quality and compliance with applicable regulations
  • Support and promote opportunity and avenues for all personnel to be involved in the assessment and management of the Quality Management System (QMS) and to contribute to continuous improvement of the QMS
  • Highly collaborative with the proven ability to work in cross-functional teams

List of Typical Responsibilities For a Director, Quality Systems Resume


Responsibilities For Associate Director, Quality Systems Resume

  • Experience in optimizing, qualifying, validating, transferring and troubleshooting analytical processes
  • HS Diploma, some college coursework in applicable curriculum and 10 to 18 years relevant experience
  • Experience in a clinical diagnostic laboratory, in a facility holding NYS DOH accreditation
  • Key leadership role in both regulation advocacy and resulting implementation strategies
  • Education: BS in Science/Engineering or relevant discipline required
  • Thorough working knowledge of OSHA, CAP, CLIA, and NYS regulatory standards
  • Write specifications for finished product and SOP’s as necessary

Responsibilities For Director Quality Systems Resume

  • Establish vendor and contract manufacturer certification program
  • Establish and maintain protocol for Warehouse GMPs including insect and rodent control, Warehouse temperature and humidity, product adulteration prevention, internal audit, and log book maintenance
  • Establish a method to insure that QC/QA employees are informed and knowledgeable of current Good Manufacturing Practice (cGMP) regulation requirements and company policies relative to personal hygiene, sanitation, wearing apparel, etc
  • Conduct investigation of product and health complaints; Manage respective reporting system
  • Keep abreast of all regulatory aspects of GMP and DSHEA, as it relates to QC/QA issues
  • Quality documentation services: develop, implement, communicate and maintain a quality plan to keep the Company’s Quality Systems and Policies into compliance with system requirements. Develops a global strategy for standardization of SOP’s and registrations, where applicable

Responsibilities For Senior Director Quality Systems Resume

  • Define and agree Quality procedures in conjunction with relevant operating staff
  • Certification management: ensure compliance with national and international standards
  • Management of QMS compliance: set up and maintain controls for the Quality Management System – CAPA, Change Management, Change Notification, Non-Conformances, Recall, Documentation Control, Product Review, Record Retention
  • Supplier Qualification Program: implement and maintain an internal audit plan and perform internal audits/ external audits including Avantor group internal audits / cross border audits
  • Validation Oversight / Global System Execution
  • Liaise with customer auditors and ensure the execution of corrective action and compliance with customers’ needs

Responsibilities For Associate Director Quality Systems Resume

  • Liaise with suppliers and ensure the execution of corrective action from audits / escalated complaints
  • Oversee recall actions and feedback relevant Recall team
  • Oversee responses to customer questionnaires, quality agreements and specifications
  • Management Review Metrics / Analysis of Data of QMS: maintain, collate and analyses Quality performance data and charts against defined parameters
  • Provide leadership and development opportunities for associates on the quality team. Make organizational decisions based on business needs and talent pool
  • Lead communication efforts to inform Avantor associates, suppliers, and customers with regard Quality Alerts and complaints
  • Oversight of the following leadership: Quality Systems and Analytical Services, Quality Management, Supplier Qualification, Validation, Quality Documentation, Change Notification, Data Integrity
  • Support / oversight (where applicable) of the following: customer audits, supplier audits, FDA inspections, ISO surveillance/re-assessment audits, regulatory bodies within the QA areas and QA agreements,

Responsibilities For Director, Quality Systems Compliance Resume

  • Supplier QA agreements, supply chain quality standards, etc
  • Responsibility for leading the annual quality planning process for the company in establishing the Quality Goals and Objectives which are ratified by the Executive Committee
  • Responsibility for ensure compliance of the Boston Scientific Global Quality System to all applicable regulatory requirements – including ISO 13485, MDD/MDR, FDA QSR, Health Canada, ANVISA, TGA, cFDA and other international requirements as applicable
  • Drive development of goals and metrics that accurately and cost effectively focus improvements in quality performances
  • Responsibility for the establishment of implementation plans for External Regulation changes which impact the Boston Scientific Quality System – example: EUMDR, GDPR, MDSAP, ISO 13485:2016
  • Responsibility for Management of Notified Body relationship
  • Oversight of Doc & Records Control (Windchill, DOCS, DocuSign, Master Data interface etc.)
  • Responsibility for External Corporate Audit Support (incl. responses)
  • Acquisition Integration Strategy Alignment

Responsibilities For Director, Quality Systems Document Control Resume

  • Responsibility for the CAPA and PIR process
  • Support Regional Quality System plans
  • Work with all sites and functions for the following quality systems processes: Quality Systems Management Review, Metrics, Change Control/Document Governance, Complaints, CAPA/Non-conformances/Investigations, Escalation, Regulatory Inspection preparedness and management, and Standards Management
  • Ensure alignment of the QMS across the site quality systems leads and deployment of quality systems based initiatives
  • Key liaison between Quality Systems department and the sites and accountable for communicating and where appropriate leading new initiatives from Quality Systems

Responsibilities For Director, Quality Systems & Compliance Resume

  • Ensure all policies, standards and procedures are effectively communicated and deployed into the sites and providing periodic updates back into Corporate, including where roadblocks and gaps exist
  • Facilitate Review boards (e.g., CAPA, Change Control, Investigations, etc.) and governance and oversight of the Quality Manual and Quality Responsibilities
  • In-depth knowledge of pharmaceutical cGMPs (US and EU)
  • Able to work hands-on in an entrepreneurial, fast paced environment
  • In RA/QA role within Medical Device industry

Responsibilities For WW Director, Quality Systems Resume

  • Oversee the Supplier Nonconformance process and ensure that supplier provides acceptable response to West’s complaint in a timely manner
  • Oversees CAP and ISO accreditation activities
  • Educates ARUP clients and prospective clients about the strengths of the Quality Management System
  • Chairs the ARUP Management Review Committee
  • ASQ Certification in applicable field
  • English: Ability to speak, read, and comprehend the English language
  • Demonstrated ability to lead through influence and expertly communicate program updates in both oral and written formats in a cross functional matrix organization is required

Responsibilities For Director, Quality Systems Resume

  • Demonstrated experience in lean/six sigma tools to lead and drive process improvements, efficiency and effective customer satisfaction (both internal and external) to ensure growth and scalability is required
  • RAC certification, ASQ - CQA, CQE or SCQE, and/or ISO Lead Assessor is desirable
  • Work in a team matrix environment and independently interact with various levels of management
  • Deep knowledge of Quality Assurance functions and practices
  • Working knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, MDR, MDSAP
  • Analyze and interpret all regulatory and quality standards and regulations
  • Understanding of FDA regulations and cGMPs with experience in deviation management, CAPAs, complaints, compliance issues, inspection trends, industry quality assurance practices and systems, and personnel management skills in a highly regulated industry

Responsibilities For Associate Director, Quality Systems Resume

  • Works independently with all levels of the organization, and has demonstrated the following skills: Rapid / Disciplined decisions, Acts with courage and candor, Drives results, Escalation of issues / concerns to management, and ability to Prioritize, Align and Simplify
  • Interpret complex business and/or technical documents, write comprehensive reports and detailed business correspondence and the ability to present to groups across the organization as needed
  • Knowledge of cGMPs, technical writing, data management collection and analysis
  • Quality Systems Track Record: Proven track record of significant accomplishments and innovation establishing progressive business practices with regard to quality systems
  • Effective Trusted Communicator: Demonstrate ability to effectively educate and influence other stakeholders of Quality Systems, encouraging ownership of quality vision and strategies; Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors
  • Experience in managing others in regulated industry

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