Director, Clinical Records, Global Head TMF Compliance and Inspection Readiness

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: January 24, 2023

Job Description:

Director, Clinical Records, Global Head TMF Compliance and Inspection ReadinessUnited States - RemoteUnited States - New Jersey - Morris PlainsUnited States - California - Foster CityUnited States - Washington - SeattleGilead 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 scaleInclusion 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 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 DescriptionGilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, CaliforniaJOB DESCRIPTION:The 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 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.QUALIFICATIONS:
  • BA or BS and 12+ years' experience in compliance and trial master file in pharmaceutical/biotechnology industry.
  • Excellent 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.
  • Strong verbal, written, communication, and interpersonal skills.
  • Ability to travel 10 -20 percent as requiredFor Colorado Job Applicants: The salary range for this position is:$170,960.00 - $256,440.00Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary. Position is also eligible for bonus and benefits. For more information, visit 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 for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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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Keywords: Gilead Sciences, Inc., San Mateo , Director, Clinical Records, Global Head TMF Compliance and Inspection Readiness, Executive , San Mateo, California