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Senior Manager, Compliance - Foster City, CA

Gilead Sciences
Foster City, CA
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Job Description

Reporting to the Director of Compliance and based out of the Foster City office you will be responsible for leading the pharmacovigilance audit program, including internal process audits and external vendor audits and you will coordinate audit follow-up and corrective action planning.


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You will maintain knowledge of pharmacovigilance regulations and company standard operating procedures for pharmacovigilance. You will ensure the completion of pharmacovigilance annual audit plans. The Compliance Manager will establish excellent working relationships with stakeholders in assigned departments and compliance/quality groups of vendors or business partners. From time to time you will be expected to assist with activities for other GxP compliance programmes, and as such you will be required to develop knowledge in these areas.

You will be responsible for providing guidance on interpretation and application of existing and new regulatory requirements to Regulatory Compliance management and assigned departments. You will assist with the provision of guidance and training to Regulatory Compliance, developing standard training modules on special topics. You will assist in the evaluation of SOPs and processes needed to comply with regulatory requirements. You will provide guidance to assigned departments and management when specific compliance issues arise. You will assist with the preparation, facilitation and follow-up of regulatory authority inspections.

The successful individual will foster a commitment to quality in individuals and a culture of quality within the organization. It is required that work is performed with little to no immediate supervision. This person will evaluate new tools as fit for purpose, they will coordinate and review the work of others. They will manage, lead or participate in various types of audits or projects involving multiple sites.

You will establish relationships and agreements with consultant auditors. You will both direct and collaborate with internal and external staff in the conduct of audits. You will be required to both lead and participate in intra- or interdepartmental teams of an operational nature such as: preparing the Company for changes in regulations, continuous improvement initiatives etc. You will initiate operational change where required and communicate change in a positive manner.
10+ years of relevant experience and a BS.
8+ years of relevant experience and an MS.
Relevant work experience consists of working in a pharmaceutical quality control, quality assurance or compliance environment.

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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 [Click Here to Email Your Resumé]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.

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For Current Gilead Employees and Contractors:

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


  • JobId: 35669
  • Posted / Updated: 2/20/2017