Senior Manager, GCP/GVP Internal and Vendor Audit Program

Gilead Sciences, Inc.
See job description.
Mar 31, 2021
Apr 09, 2021
Jobseeker Type
Organization Type
Part Time
Senior Manager, GCP/GVP Internal and Vendor Audit Program, R&D Quality and Compliance
Ireland - Dublin

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs?

We are looking for a Quality and Compliance Sr. Manager who is ready to dive-in to support our clinical development and post-marketing safety programs. As a Quality and Compliance Sr. Manager, you will support global GCP & GVP compliance activities that include the Internal Process and Vendor Audit Programs and Inspection Management activities. You will work closely with internal functional stakeholders, study management teams and external stakeholders.

This role is suited to candidates who possess a strong proactive quality mindset, strategic thinking ability and project management skills. Utilizing expert GCP/PV knowledge, you will be a trusted business partner effectively communicating and collaborating with internal and external stakeholders and the R&D Quality and Compliance Management Team.

You will be a part of an expert and supportive team that fosters constructive collaboration in support of our clinical development and post marketing programs.
Primary Responsibilities
  • Support execution of the global activities for Gilead's global GCP/GVP Internal Process and Vendor Audit Programs.
  • Perform risk assessment and develop audit strategy for assigned areas
  • Support and/or lead GVP routine and complex audits for Gilead Affiliate offices, distributors, external partners, and vendors
  • Support and/or lead GCP Internal Process audits.
  • Support and/or lead GCP Vendor Audits
  • Liaises with internal Gilead business functions in compliance activities
  • Support/lead inspection readiness preparation, and/or directly support regulatory agency inspection as needed.
  • Support review of operating procedures (e.g. SOPs) and perform other activities in support of an integrated cross-functional quality management system (QMS).
  • Effective compliance reporting to senior management and relevant quality governance forums.
  • Report and investigate compliance issues
  • Support CAPA development and perform effectiveness checks of CAPAs
  • Represent Quality & Compliance in cross functional working groups & initiatives
  • Fosters a commitment to quality in individuals and a culture of quality within the organization.
  • Provides expert, timely and risk-based guidance in line with regulations & business needs
  • Direct contract auditors and others who oversee activities performed by contract auditors.

Sr. Manager: Qualifications
  • BA or BS and 8+ years of relevant experience (6+ years of relevant experience with an MS).
  • GCP audit and compliance experience required.
  • Bio-pharma sponsor experience required.
  • PV audit experience strongly preferred.
  • Inspection management experience preferred.
  • Strong verbal and written communication skills and interpersonal skills.
  • Experience with audit management/CAPA management programs strongly preferred.
  • Excellent organization skills and project management.
  • Able to work equally well as part of a team or independently

About Gilead R&D Quality and Compliance

Gilead R&D Quality and Compliance is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team.

We are a committed team of highly skilled Quality and Compliance professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.

We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.

Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?

Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

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