Quality / Compliance Resume Sample

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Elda Abshire
74127 Josefina Freeway,  Dallas, TX
+1 (555) 810 1617

Work Experience

Assistant Manager CLS, Quality & Compliance
10/2016 - PRESENT
San Francisco, CA
  • Significant experience in research and interpretation of Workers’ Compensation state statutes and regulations via the internet or other media
  • Experience in workers’ compensation claims management, bill review, or occupational case management
  • Coordinates and conducts routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards and other applicable requirements[i.e. QMS, QSIT, Combination Products, Regulatory requirements; PAL, TGA, Notified Bodies, etc.]
  • Coordinates and conducts routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards..[i.e. QMS , QSIT, Combination Products, Regulatory requirements; PAL, TGA, Notified Bodies, etc]
  • Based on BSSCKL’s chosen compliance programs, carry out a systematic internal appraisal of the effectiveness of the policies, procedures and standards
  • Work with all levels of management to validate audit comments and recommendations for improvement
  • Add value by acting as an internal consultant to strengthen and improve internal controls effectiveness
  • Monitor delivery team’s response and implementation on internal and external audit recommendations
  • Apply procedures to ensure accuracy of output and share best practices with delivery teams
Quality Compliance Analyst
12/2010 - 05/2016
San Francisco, CA
  • The vigilance report is prepared and approved according to the internal procedures, the authorities are informed and the vigilance files are part of the Complaint file
  • The Device History records are reviewed
  • The root cause is identified when applicable
  • The complaint file is closed within the time established
  • The PRA’s and CAPA’s linked to the investigation are part of the file
  • The trends for the failure are performed, reviewed and included in the file
  • The customer is informed when required
  • Provides technical support for external and internal customer inquiries
  • Establish, maintain and improve Standard Operating Procedures (SOP’s) for quality with contract manufacturers and warehouse operations
Intern Quality Compliance
02/2007 - 09/2010
Chicago, IL
  • Assist delivery teams to improve service performance quality based on fact finding during internal audit process
  • Consistently exhibits behavior and communication skills that demonstrate HealthCare Partners’ (HCP) commitment to superior customer service, including quality, care and concern with each and every internal and external customer
  • Uses, protects, and discloses HCP patients’ protected health information (PHI) only in accordance with Health Insurance Portability and Accountability Act (HIPAA) standards
  • Relevant documentation regarding complaint files is compiled and included in the Quality Management System
  • The complaint is codified according to the procedures and according to the information received
  • The reportability to the authorities is determined according to the internal procedures
  • Imagery supporting the report is collected and reviewed for evaluation
  • Product for evaluation is shipped and evaluated


Western Carolina University - Asheville
2002 - 2007
Bachelor's Degree in Business Administration

Professional Skills

  • Strong skills in working independently and to effectively interact with various levels
  • Excellent Writing and Technical Skills
  • Strong Microsoft Excel, PowerPoint and computer skills
  • Strong technical, business and relations skills directed related to a broad range of compliance areas
  • Excellent written and verbal communication skills including development of effective presentations
  • Excellent Microsoft Office skills required particularly Excel and PowerPoint
  • Knowledge and use of relevant PC software applications including Microsoft Word and Excel and skill to use them effectively

How to write Quality / Compliance Resume

Quality / Compliance role is responsible for microsoft, technical, compliance, regulatory, computer, development, reliability, organization, leadership, powerpoint.
To write great resume for quality / compliance job, your resume must include:

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

Contact Information For Quality / Compliance Resume

The section contact information is important in your quality / compliance 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 Quality / Compliance Resume

The section work experience is an essential part of your quality / compliance 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 quality / compliance responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality / compliance position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Quality / Compliance resume experience can include:

  • Demonstrated analytical skills, both quantitative and qualitative, problem solving and strategic planning skills
  • Excellent writing skills and verbal skills are required
  • Written and verbal communication skills including technical writing skills in English & Spanish languages
  • Demonstrated problem-solving , critical thinking, and investigative skills working relationships
  • Demonstrable project management skills; experience working in cross-functional teams
  • Detail-oriented with strong analytical, problem solving and organizational skills

Education on a Quality / Compliance Resume

Make sure to make education a priority on your quality / compliance resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality / compliance 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 Quality / Compliance Resume

When listing skills on your quality / compliance 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 quality / compliance skills:

  • Strong analytical skills and experience implementing risk-based oversight programs across multiple sites or Corporate experience
  • Excellent presentation & communication skills and the ability to interface effectively with all levels of the organization is required
  • Demonstrates strong technical skills. Provides technical assistance to area supervisors or managers to solve complex problems
  • Strong problem solving and time management skills are required
  • QA systems audit experience is desirable with well-developed risk assessment skills
  • A good communicator who can effectively influence and instil accountability in others

List of Typical Experience For a Quality / Compliance Resume


Experience For Quality Compliance Analyst Resume

  • Strong written, verbal and presentation skills along with demonstrated ability to collaborate with others
  • Auditing and Report writing skills
  • Experience in quality control and Good Manufacturing Practices
  • Report writing and oral communication skills
  • Experience with database software and design software. Knowledge of Crystal reporting. SAP experience desired

Experience For Assistant Manager CLS, Quality & Compliance Resume

  • Analyze and interpret such information to effectively perform position responsibilities
  • Experience in Quality Assurance or Compliance Management related role, with strong Quality Management Systems knowledge
  • Prior data analysis experience
  • Quality or Compliance experience in an FDA and/or ISO regulated industry with demonstrated knowledge of applicable standards and regulations
  • Understanding of document management, training design principles, curriculum development, adult learning theories, and training effectiveness
  • Scientific experience, including both hypothesis-generating, hypothesis-testing and/or publications
  • Experience in a regulatory compliance position supporting the manufacture and testing of pharmaceutical products

Experience For Senior Manager Quality Compliance Resume

  • Experience including managing the design, implementation and maintenance of quality practices in a regulated environment
  • Experience in independently drafting field alert notifications for the FDA or notifications to other health authorities
  • Experience working with regulatory authorities and certification bodies is required
  • Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office
  • Experience in CSV and IT QA & Compliance in FDA regulated industry or equivalent including health authority inspections
  • Experience managing 3rd party providers
  • Experience of Quality Monitoring
  • Excellent knowledge of the following regulation areas as they pertain to quality systems: QSR, ISO, CMDR, MDD, MHLW. Knowledge of ANVISA and TGA is desired

Experience For Assistant Director Pharmacovigilance Quality & Compliance Resume

  • Experience supporting external inspections
  • Internal and external auditing experience
  • Strong understanding of 21 CFR, ICH Q7-Q10, E6 and ISO13485
  • Experience and working knowledge of analytical laboratory practices, methods, procedures and quality assurance in support of production
  • Risk and compliance assessment, planning and implementation experience
  • Experience with designing protocols, case report forms, regulatory submissions, etc

Experience For Dir., Quality Compliance Resume

  • Experience managing CAPAs in the Medical Device Industry desired
  • At least five (5) years’ related work experience auditing (internal/supplier) in a cGMP environment
  • One-year experience working in the applicable client’s payment system
  • Provides guidance to less experienced staff. Influence exerted at peer level and occasionally at first levels of management
  • Continually evaluates effectiveness of training programs, recommends and/or develops revisions as needed
  • Experience in coordination/participation of HA Inspections is essential

Experience For Senior Quality Compliance Analyst Resume

  • Experience in Internal/Vendor Audits an advantage
  • Ensuring effective operation of the Quality Assurance function and continuous improvement in quality and productivity
  • Hands on experience performing system, unit, acceptance, regression, load and functional/performance testing
  • Experience in equipment qualification is required
  • Experience in a cGMP production facility
  • Work experience with computer operations processes
  • Work experience in a Service Desk or Call Center

Experience For Associate Director, Quality Compliance Resume

  • Building interdependent partnerships, acting as the mediator between operating units while optimizing the value proposition
  • Building consensus and impacting outcomes without always having line authority; able to negotiate trade-off decisions across the organization
  • Managing Operating and Capital budgets for respective function
  • Managing Consumer Complaints
  • Working within a direct and indirect organization that delivers results
  • Understanding of the global regulatory landscape (e.g. European regulations such as annex 11) and ability to apply global best practices to daily tasks
  • Understanding of applicable global regulatory requirements and corporate policies is required

Experience For Associate Director, Global Quality Compliance Resume

  • Understanding of GCC processes and consumer privacy policies an asset
  • Summarize findings, including a review of the investigation, product analysis, imaging review,
  • Instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
  • Assist in training programs, as needed (e.g. new hire training)
  • Provide on-going reporting on quality and compliance metrics
  • Normal manufacturing, laboratory and office situation
  • Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations

Experience For Manager Quality Compliance Resume

  • Evaluate complaints for Medical Device Reporting (MDR)
  • Manage customer relationship and expectations during course of complaint investigation and resolution process
  • Support the external standards/regulations assessment process for evaluating impact to LifeCell’s products, processes and quality system
  • Manage supplier set up process inclusive of factory audit review and managing CAP plans
  • Oversee import banking and import compliance timelines and tasks
  •  Provide assurance over the accuracy and integrity of contact monitoring via collaboration sessions, best practice and assessments
  • Identify and resolve deficiencies by training staff on requirements

Experience For Manager, Quality Compliance Resume

  • Serve as SGEN’s business process owner for internal and external audits, inspection management and product complaint handling
  • Independently reviews Manufacturing Procedures, SOPs, and other documentation to ensure compliance with commitments, regulations and filings
  • Build partnerships both internally and externally. Makes the customer central to all thinking.1700161230W
  • Travel approximately 30 - 70%, including internationally
  • Participate and lead in analyzing operational opportunities for improvement and present findings and recommendations to the appropriate teams for action
  • Expert understanding of US FDA and international regulatory standards for medical devices
  • Balanced technical understanding of products and processes combined with superior business and compliance acumen
  • Stand firm while being open to new approaches

List of Typical Skills For a Quality / Compliance Resume


Skills For Quality Compliance Analyst Resume

  • Provide audit of method validation protocols, reports and associated analytical data and supporting validation work for submissions
  • Good understanding of manufacturing operations & quality management systems
  • Experience in data/statistical analysis and problem solving techniques
  • Review and approve method validation protocols and reports in support of corrective and preventative action (CAPA) in support of analytical investigations
  • A science graduate with experience in a GMP or other regulated industry
  • Assist with implementing tracking and filing process for managing the SABR Secure file room documentation

Skills For Assistant Manager CLS, Quality & Compliance Resume

  • Aseptically gown and work in a controlled processing environment working with human and animal tissues
  • Partners closely with manufacturing, engineering, and other functional groups on regulatory compliance issues
  • Provide support for tracking and responding to Health Authority correspondences (ie, Compete Response Letters, Information Requests, etc)
  • Oversee and maintain the site’s internal audit program by maintaining the internal audit schedule and performing internal audits
  • Takes responsibility for fulfilling FDA and international regulatory requirements relevant to daily tasks and each project, such as cGMP and ISO
  • Perform compendial review and maintain status tracking to ensure compliance with current compendial and regulatory standards

Skills For Senior Manager Quality Compliance Resume

  • Evaluate Purchasing changes (e.g., alternate material and supplier sources, supplier site changes, etc)
  • Evaluate Purchasing changes (e.g., alternate material and supplier sources, supplier site changes, etc.)
  • Knowledge of the legal requirements, rules and guidance covering the manufacture of pharmaceutical products in Europe
  • Microsoft products such as Word, Excel, Project, and Visio
  • 7 days in / 7 days out work schedule
  • Manages the Quality Compliance department
  • Independently carry out analysis and develop recommendations
  • Knowledge of Sky’s products and services, ideally gained within Sky’s contact centre
  • Present to the highest levels

Skills For Assistant Director Pharmacovigilance Quality & Compliance Resume

  • Routinely diagnose problems and recommend solutions
  • Develop knowledge in FDA and international regulations relevant to each project, i.e., cGMP, and ISO
  • Self-starter with the ability to follow through and deliver tasks in a timely manner
  • Performs varied quality/regulatory activities (ex. Adverse Event Reporting, CAPA, Field Actions, Audits, Document Control) and ensures tasks are completed in compliance with regulatory and internal requirements
  • Maintains quality data and related reports that are accurate and concise
  • Maintains regulatory required records per record retention requirements

Skills For Dir., Quality Compliance Resume

  • Designs and performs routine analysis of data and reports results on an independent basis
  • Develops or participates in the development of solutions to problems of moderate to intermediate compliance complexity. Interprets, executes, and recommends modifications to operating policies where appropriate
  • Identifies areas where the business can effect quality system improvements
  • Update analytical methods in Documentum and initiate QC Laboratory based change control for regulatory submission and product development
  • Assist in the review of analytical documentation in support of site transfer activities

Skills For Senior Quality Compliance Analyst Resume

  • Review analytical assessments in support of new excipients for Product Development
  • Provide Quality Compliance and Regulatory guidance for the Quality Control (QC) Laboratory
  • Interface with Regulatory Affairs and other departments and third parties as necessary
  • Lead and/or performs laboratory investigation activities to ensure compliance with procedural and regulatory requirements by facilitating investigation activities, providing analysis of data related to laboratory investigations, and organizing and leading cross functional investigations as required
  • Evaluate the need for Corrective and Preventive Action(s) (CAPAs) and supervise and maintain the site’s CAPA program. Identify and implement system improvements (CAPAs) and evaluate effectiveness of CAPAs
  • Evaluate potential investigation/CAPA trends, identify root cause of trends, and implement trend CAPAs

Skills For Associate Director, Quality Compliance Resume

  • Oversee and maintain the performance of Annual Product Reviews (APRs) / Continuous Process Verification (CPV) associated with manufacturing, packaging and release by performing APRs / CPVs and completing data analysis and evaluation
  • Provide investigation, CAPA, complaint and audit information required for APRs, CPVs, Management Review, Site Metrics and other business needs and assist with KPI metrics reporting and evaluation
  • Perform audit of method validation protocols, reports and associated analytical data and supporting validation work for submissions
  • Providing trending, analysis, and reporting related to Altria’s operating companies product quality issues
  • Providing disposition authorization for escalated PQI’s

Skills For Associate Director, Global Quality Compliance Resume

  • Provide support for tracking and responding to Health Authority correspondences (i.e., Compete Response Letters, Information Requests, etc.)
  • Performs laboratory investigation activities to ensure compliance with procedural and regulatory requirements by facilitating investigation activities, providing analysis of data related to laboratory investigations, and organizing and leading cross functional investigations as required
  • Strong knowledge of and experience with processes involved in manufacturing
  • Previous experience with upstream processing of Drug Substance and/or Quality Control testing in a cGMP facility
  • Evaluate the need for Corrective and Preventive Action(s) (CAPAs) and identify and implement system improvements (CAPAs) and evaluate effectiveness of CAPAs
  • Performs manufacturing and complaint investigation activities to ensure compliance with procedural and regulatory requirements by facilitating investigation activities, providing analysis of data related to manufacturing and complaint investigations, and organizing cross functional investigations as required

Skills For Manager Quality Compliance Resume

  • Strong knowledge in Good Distribution Practices
  • Participate in the site’s internal audit program by maintaining the internal audit schedule and performing internal audits
  • Assist with the execution of Annual Product Reviews (APRs) / Continuous Process Verification (CPV) associated with manufacturing, packaging and release by performing APRs / CPVs and completing data analysis and evaluation
  • Provide input and guidance to the team conducting incident investigations
  • Make recommendations to department management regarding results of investigations and process improvements
  • Ensure a constant state of inspection readiness and all audit observations are addressed
  • Manage our quality systems to ensure that corrective and preventative actions are completed
  • Partner with Finance, Risk and Internal Controls Services, Finance Centers, and other units to define quality and compliance objectives

Skills For Manager, Quality Compliance Resume

  • Engage other institutions and organizations to identify relevant methodologies and trends in higher education
  • Partner with Finance, Risk and Internal Controls Services, Finance Centers, and other units to identify and align on operational, compliance, and quality performance metrics
  • Analyze financial and operational data to formulate recommendations in establishing performance targets
  • Collaborate with Finance, Risk and Internal Controls Services and Finance Centers to identify and design processes, procedures, and reports required to support the strategy and establish the proper balance between risk and efficiency
  • Design monthly/quarterly performance reporting package
  • Collaborate with ITC to align functional requirements with system / reporting requirements
  • Partner with Finance Leadership to develop project plan and communicate plan to key stakeholders
  • Reviewing and providing guidance as needed to Altria’s operating companies related to the investigation, documentation and potential impact of product quality issues
  • Participating in the development of Altria-wide Factory Conformance Analysts through training and/or mentoring to increase the overall organizational capability

List of Typical Responsibilities For a Quality / Compliance Resume


Responsibilities For Quality Compliance Analyst Resume

  • Interact with market leaders, other departments, and the community to promote Humana programs and strategic initiatives. Implement these in the Quality area to align with Humana’s programs and strategy
  • Demonstrated problem-solving , critical thinking, and investigative skills Ability to build stable working internal/external relationships
  • Demonstrated working experience with Trackwise and SAP systems
  • Demonstrated experience in leading people or projects
  • Experience in developing an organizational “culture of compliance” and defining a quality system
  • At least eight years of directly relevant experience of working within a highly regulated environment (e.g. healthcare or research)
  • Help deliver an exceptional client experience by improving the performance and quality of the Client Services team
  • Provide feedback to the management team to ensure the timely and effective corrective action

Responsibilities For Assistant Manager CLS, Quality & Compliance Resume

  • Quality Assurance experience in a Pharma/Vaccine production facility
  • Previous experience with Drug Substance and/or Drug Product cGMP Facilities
  • Developing and delivering training programs
  • Identifying data streams and defining and implementing metrics
  • Training with problem solving methods such as KTA’s, HACCP, or equivalent
  • Developing and implementing procedures and systems
  • Challenging auditors’ findings to ensure they are warranted

Responsibilities For Senior Manager Quality Compliance Resume

  • Conducting investigations on certification non-conformance and the certification suspension in accordance with Proc MB04
  • Aseptic processing expertise. Has a broad understanding of aseptic processing and compliance/regulations
  • Prepare and deliver QS related training consistent with internal procedures and regulations to manufacturing personnel
  • Follow-up response to required, Corrective, and Preventive Actions to assure they are being followed in the manufacturing areas
  •  Manage ongoing/new training and ensure changes are fully briefed with the QA team (Agylist)
  • Provides resource and strategy support during internal and external compliance audits including logistics, backroom support and Subject Matter Expert roles
  • Participate in industry-wide meetings for purpose of benchmarking and seeking out improved compliance methodologies

Responsibilities For Assistant Director Pharmacovigilance Quality & Compliance Resume

  • Develop and implement all necessary tools to support the process and provide mentoring and support as needed
  • Support communications and training to ensure cross-team awareness of quality processes, policies, and tools
  • Manage performance of suppliers / buying agent / third party provider / Jo-Ann Quality team in Asia in terms of factory audits and quality assurance
  • Ensure mandatory testing protocols are adhered to on all applicable products and develop any custom protocols specifically for Jo-Ann as necessary
  •  Ensure the accuracy and integrity of all quality monitoring information and insight provided to the business (within area of control)
  • Monitor revisions to product impacting standards and regulations
  • Collect quality system process data from different parts of the company for analysis and reporting in business and quality system meetings

Responsibilities For Dir., Quality Compliance Resume

  • Knowledge of the CMS Medicare Marketing Guidelines
  • Perform trending on investigations and observations to ensure global awareness and the development of proactive process improvements in all regions
  • Perform and/or coordinate the training of GCC employees in appropriate compliance practices
  • Makes decisions on behalf of the company on the acceptability of compliance ongoing activities
  • Serves as an expert in current and emerging regulatory requirements and industry best practices
  • Responsible for associated Quality Compliance budget supporting the quality programs

Responsibilities For Senior Quality Compliance Analyst Resume

  • Oversees preparation of professional compliance documents, materials and reports required for CMS contracts, State Medicaid contracts, and NCQA accreditation
  • Reports compliance submission activities and results and identifies necessary improvement action plans needed to close Gaps
  • Direct the development and implementation of quality strategies, programs and policies
  • Establish a Quality Management System that includes
  • Create the strategy and direct the activities required assuring compliance with applicable local government regulations and industry accepted standards that govern clinical studies
  • Provide oversight and direction in all activities leading to or potentially leading to a regulatory filing (e.g. Pre-market Approval [PMA], Investigational Device Exemption [IDE], 510(k), Biologic License Application (BLA), New Drug Application (NDA), FDA-mandated post market studies, CE-marking)
  • Assessing and Resourcing BRQC Capability in Support of Business Partner Requirements: Be an integral part of business partner strategy and business planning processes
  • Support the administration of the Company’s training program, and conduct Good Clinical Practices training to internal Clinical Departments and externally, if applicable

Responsibilities For Associate Director, Quality Compliance Resume

  • Ensure qualified personnel, including knowledge, experience, and independence, performs the audits
  • Stays abreast of regulatory updates and guidance’s to ensure compliance of Horizon processes and procedures
  • Establish and maintain robust compliance program. Ensuring compliance to local, national and international regulatory standards, company policies and procedures, and J&J Corporate requirements
  • Partnership with JJRC teams in order to coordinate the implementation of internal and external audit schedules
  • Establish and maintain regulatory inspection readiness plan at each site in preparation for any regulatory inspection (internal and external). Supports manufacturing site regulatory inspections as required
  • Partnership with appropriate teams on the formulation of responses to regulatory agencies in order to address observations. Collaborate with other business partners in the identification and implementation of corrective actions. Ensure effective and timely completion of all third party commitments
  • 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. Ensure results of monitoring process are routinely communicated to management through Site Management Review process and other forums as applicable

Responsibilities For Associate Director, Global Quality Compliance Resume

  • Supervise compliance personnel according to Human Resources policies and procedures, including hiring, training, and mid/end-year performance appraisals
  • Assure all external auditing companies meet internal requirements
  • Maintain the compliance dashboard for on-time Management reporting
  • Manage the relationship and contract with the Notified Bodies from a compliance perspective
  • Serve as a subject matter expert, as needed, to support proactive or reactive responses to issues
  • Standardize and leverage MD Regulatory Compliance policies, practices, metrics and resources across the sector
  • Monitor Cuve Database for Field Action, Regulatory Inspection and QScan data accuracy and completeness
  • Provide leadership and development to all direct reports assuring active participation in performance management, succession planning and talent development activities

Responsibilities For Manager Quality Compliance Resume

  • Ensure all direct reports comply with Health and Safety requirements
  • Provide proactive compliance support regarding research best practices, document control, process development/improvement and risk management. Enhance and implement Flatiron’s quality system to ensure compliance with applicable regulatory requirements. Assess internal compliance with Flatiron’s quality system
  • Ensure proactive audits/inspection readiness. Oversee all external audits/inspections of Flatiron’s data and research businesses, including liaising with clients, hosting on-site visits, and internal oversight of associated action plans. Plan, facilitate, document and closure audits of Flatiron vendors
  • Proactive compliance support methodology that can translate complex regulatory principles into best practices for cross-functional research teams
  • A flexible approach to compliance; ability to translate and infuse compliance knowledge and best practices into research deliverables

Responsibilities For Manager, Quality Compliance Resume

  • Strong working knowledge of US FDA regulations and ICH- GCP guidelines. Familiarity with regulations and the associated guidance documents relevant to clinical trials (e.g. 21 CFR parts 50, 312, 812) and electronic data (e.g. 21 CFR Part 11)
  • Clinical trials and/or clinical research operations experience, such as oversight of multi-center clinical research activities including participant screening and recruitment, oversight of clinical research organization and/or vendors supporting research
  • Experience drafting, reviewing, implementing and ensuring compliance with research procedures (SOPs) that drive efficiency and foster a creative approach to solving business needs
  • Work within cross-functional team and manage multiple simultaneous projects
  • Lead & Coordinate with Procurement and impacted Site Quality leads on critical audit findings and or audit refusals. Generate comprehensive presentations/summary of issues for effective communication to all levels, ensuring required assessments are performed
  • Actively provide individual/team’s contributions in problem solving efforts to improve quality
  • Initiates NCRs via Agile system, assesses impact, proposes action, and assures all conditions of action plan are met

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