Sr. Director, TMF Compliance and Inspection Readiness

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.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

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

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description


POSITION:

SR DIRECTOR, TMF COMPLIANCE & INSPECTION READINESS

Location:

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.

MINIMUM QUALIFICATIONS:

• 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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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 'Know Your Rights' poster.

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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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