Gilead Sciences, Inc. Senior Director, Compliance in Foster City, California

For Current Gilead Employees and Contractors:

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

Job Description

Gilead is a research-based biopharmaceutical 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. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Within the Gilead family, Kite Pharma are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination therapy. With an unrelenting drive and a singular focus on our strategy to bring life-saving therapies to patients.

Specific Job Responsibilities:

  • Area of responsibility may be limited to Clinical Compliance, Laboratory Compliance, or Electronic Systems Compliance.

  • Fosters a commitment to quality in individuals and a culture of quality within the organization.

  • Work is performed with little to no immediate supervision. Evaluates new tools as fit for purpose.

  • Coordinates and reviews the work of others.

  • Manages and/or leads various types of audits or projects involving multiple sites or therapeutic areas.

  • Directs others in the oversight of activities performed by contract auditors.

  • Establishes relationships and agreements with contract auditors.

  • Evaluates departmental and business area SOPs for fit for purpose and in compliance with regulatory requirements.

  • Ensures adherence to departmental across sites.

  • Leads intra- or interdepartmental teams of an operational nature such as: preparing the Company for minor changes in regulations, continuous improvement initiatives.

  • Purpose is for input and obtaining information for dissemination intra- or interdepartmentally.

  • Assists in readiness for and regulatory agency inspections. Assists in the coordination of responses to any regulatory agency findings.

  • Developing and presenting training using standard modules and training on special topics.

  • Ensures appropriate content of training modules.

  • Initiate operational change where required and communicate change in a positive manner.

  • Considers a number of factors in planning, anticipate work and prioritize work to meet tight timelines.

  • Direct others in prioritizing their work.

  • Define systems or processes to consistently ensure the high standards required in Compliance.

  • Checks perspective of others and adapts communication approach accordingly.

  • Builds positive support for position outside of formal meetings.

  • Determines most efficient and appropriate method of communication in a variety of situations.

  • Understands impact of decisions and actions on business and consults with appropriate colleagues and management as applicable.

  • Promotes and maintains productive working relationships.

  • Mentors others in establishing good working relationships.

  • Addresses sensitive issues in an objective manner.

  • Must have a thorough knowledge of regulatory requirements for assigned territories.

  • Is recognized as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource.

  • Understands current global and regional trends in regulatory compliance.

Specific Education & Experience Requirements:

  • 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.

Meet the team:

https://regulatoryaffairs-careers.gilead.com/

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For jobs in the United States:

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.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ at http://www.eeoc.gov/employers/upload/posterscreenreader_optimized.pdf poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT at http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT at http://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

PAY TRANSPARENCY NONDISCRIMINATION PROVISION at https://www.dol.gov/ofccp/pdf/PayTransparencyNotice_JRFQA508c.pdf

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.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead