Sr. Director, TMF Compliance and Inspection Readiness
United States - California - Foster City
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. Gilead’s 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 company’s five core values. That’s 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.
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Job DescriptionPOSITION: SR DIRECTOR, TMF COMPLIANCE & INSPECTION READINESSLocation: This is a hybrid/office based position located in:FOSTER CITY, CA or PARSIPPANY, NJ or Seattle, WA
The Sr. Director, Global Head - TMF Compliance and Inspection Readiness is responsible for progressing TMF compliance across Gilead leading the internal Clinical Records TMF quality and compliance group. This group ensures functional teams operate in compliance with GCP quality standards and regulatory requirements. The position represents Clinical Records in internal process audits, GCP/GxP inspections, and enterprise initiatives impacting TMF resources, GCP/GXP best practices. processes, and systems. PRIMARY RESPONSIBILITIES:
- Lead Clinical Records organization and oversee strategy for TMF in accordance with regulations, SOPs and records retention policies.
- Lead global TMF compliance through strategy, planning, and execution of inspection readiness programs.
- Provide guidance to functional teams to ensure TMF compliance with regulations and requirements.
- Analysis of TMF data to proactively identify and alert the organization of TMF quality or compliance concerns.
- Directly support internal process audits and regulatory inspections as the TMF subject matter expert.
- Advise on Corrective and Preventative Action (CAPA) remediation and resolution of TMF issues identified through audits, inspections, and other compliance assessments.
- Develop and execute on TMF metric strategy.
- Champion the use of master data, integration, and strategic use of artificial intelligence to provide transformative capabilities to Gilead and Kite.
- Influence future TMF direction and capabilities by identifying and leading activities which build efficiencies, automation, standardization, and adoption of best practices across Gilead and Kite.
- Collaborate with key internal and external stakeholders to assess process alignment and prioritize procedural and TMF system changes to ensure continued improvements and compliance.
- Represent Clinical Records in cross-functional projects, initiatives, and compliance forums.
- Serve as a ambassador of Good Documentation Practices to ensure compliance with regulations, internal procedural documentation, and data integrity.
- Hire and manage resources as needed to support TMF compliance and inspection readiness.
- Bachelors Degree and 14+ years OR Master Degree and 12+ years of experience in Clinical Operations compliance and trial master file in pharmaceutical/biotechnology industry
- Demonstrated working knowledge of GCP regulations
- Direct experience at the sponsor level with front and back-room inspection operations
- Ability to build strong relationships to foster a collaborative approach to proactive compliance activities
- Document Records Management experience using electronic TMF platforms
- Proven effective verbal, written, communication, and interpersonal skills
- Ability to travel 10 -20 percent as required
- Demonstrates Gilead People Leadership Commitments: Develop Talent, Create Inclusion, Empower Teams
The salary range for this position is: $230,860.00 - $298,760.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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