Sr. Manager, R&D Quality Compliance /GCP GVP Auditor

Location: Foster City, California US

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Job Number: 1758

External Description: Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description Senior Manager, GVP, GCP and Internal Audit, R&D Quality and Compliance
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 GVP compliance activities as well as GVP and GCP Internal Audit Programs working 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 Good Pharmacovigilance (GVP) and Good Clinical Practice (GCP) 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 development of Global GVP audit plan
  • Perform risk assessment and develop audit strategy for assigned areas
  • Manages and/or leads GVP routine and complex audits for internal processes, Gilead Affiliate offices and external partners and vendors
  • Support GCP Internal Process audits as a lead auditor or co-auditor
  • Liaises with PVE management and other internal stakeholders to execute PV compliance activities
  • Represent Regulatory Compliance in PV-related Working Groups as appropriate
  • Assists in readiness preparation, and/or directly support regulatory agency inspection.
  • Evaluate, write and/or review 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 critical compliance Issues
  • Support CAPA development and perform effectiveness checks of CAPAs
  • 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.


Qualifications
  • BA or BS and 8+ years of relevant experience (6+ years of relevant experience with an MS).
  • Must have audit and compliance experience.
  • Bio-pharma sponsor 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

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Number: R0013798

Community / Marketing Title: Sr. Manager, R&D Quality Compliance /GCP GVP Auditor

Location_formattedLocationLong: Foster City, California US

 

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