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Director, R&D Quality Assurance Compliance - GCP & PV

For Current Gilead Employees and Contractors:

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

Job Description

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 Director of Quality and Compliance who is ready to dive-in to support our clinical development programs. As a Director of Quality and Compliance, you will support and work with our clinical study management teams, our Pharmacovigilance teammates across R&D Quality and Compliance and other key stakeholders as needed.

We need leaders with strong Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) knowledge, audit skills, communication, facilitation skills, and the ability to manage multiple projects. You will be a part of an expert and supportive team that fosters constructive collaboration in support of our clinical development programs.

Primary Responsibilities

  • Serve as Compliance Lead for overseeing our internal audit program. Handle multiple projects and ensure overall and timely completion of tasks.
  • Leads development of audit plan for assigned projects and manages audit plan execution.
  • Manages and/or leads GCP /PV routine and complex audits, specifically internal processes.
  • Trains and manages contracts auditors.
  • Works closely with key stakeholders to provide expert compliance information, manage identified issues, and support continuous improvement.
  • Maintains awareness of key issues and concerns and escalates to Senior Management as appropriate
  • Assists in readiness preparation, and/or directly support regulatory agency inspection. Assist in coordination of response to any findings.
  • Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
  • 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).

Minimum Qualifications

  • Bachelor’s degree with 12+ years; Masters degree with 10+ years; or PhD with 8+ years of R&D quality assurance compliance experience
  • Must have significant GCP / PV audit and compliance experience
  • Bio-pharma industry experience highly preferred
  • Recognized as an expert resource on a range of compliance topics
  • Demonstrated effective verbal and written communication skills and interpersonal skills
  • Proficiency with Microsoft Office suite
  • Experience with audit management/CAPA management programs strongly preferred
  • Strong organization skills and project management experience
  • 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?

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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 for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.



Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

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

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