Director, Clinical Records, Global Head TMF Compliance and Inspection Readiness
Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: January 24, 2023
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
- 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
- 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
- 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
- Ability to build strong relationships to foster a collaborative
approach to proactive compliance activities.
- Document Records Management experience using electronic TMF
- Strong verbal, written, communication, and interpersonal
- 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
Keywords: Gilead Sciences, Inc., San Mateo , Director, Clinical Records, Global Head TMF Compliance and Inspection Readiness, Executive , San Mateo, California
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