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Associate Director, Clinical Quality Operations Excellence, R&D Quality & Medical Governance

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Apr 27, 2022

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Job Details


Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs?

We are looking for an expert Quality Assurance Professional with Good Clinical Practices (GCP) and Electronic Systems Compliance (ESC) experience who is ready join our Clinical Quality Business Partners team within Global R&D Quality & Medical Governance. As a member of the Clinical Quality Operations Excellence team you will provide leadership and subject matter expertise within R&D Quality & Medical Governance as well as to other key functional stakeholders for clinical development programs at Gilead.

This role is suited to candidates who possess strong leadership skills and strategic risk-based thinking. Utilizing expert GCP and ESC knowledge this role will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization. You will be a part of an expert team supporting compliance in clinical development programs at Gilead.

Primary Responsibilities
  • Advance the understanding of how clinical data and the systems used to record, transfer, analyze and report that data supports of clinical development programs and meets regulatory requirements ensuring data integrity and patient safety.
  • Act as R&D Quality and Medical Governance strategic advisor for functional areas such as Clinical Data Sciences, Clinical Pharmacology, Biomarker Sciences, and Clinical Operations
  • Assures Quality review of key SOPs related to data planning and management (e.g. data monitoring committees, unblinding of clinical trial data, etc...)
  • Serve as the Clinical Quality Business Partner lead for Clinical Data Sciences supporting cross portfolio initiatives
  • Key partner and R&D Quality & Medical Governance POC for Clinical Data Sciences Bridge Quality Team
  • Gain insights from metrics and other mechanisms to uncover trends and/or gaps in data integrity and advise business on any mitigation requirements
  • Lead Clinical Data Sciences Quality forum and assure management visibility of Quality performance across Clinical Data Sciences
  • Partner with relevant functional areas to gap assess, investigate and problem solve issues posing risk to data integrity across Gilead's clinical portfolio
  • Key advisor on multiple cross portfolio projects and/or initiatives contributing timely completion of R&D Quality & Medical Governance tasks
  • Contribute to the development and analysis of a data integrity risk register for readout to Gilead key business areas
  • Provide timely risk-based compliance advice that facilitates decision making
  • Partner/advise functional area in the development & investigation of internal deviations or CAPAs
  • Support Clinical Data Sciences, or other relevant functional area in preparation for regulatory agency inspections of Gilead as needed (i.e. identify and mitigate inspection risk/ storyboarding)
  • Supervise, develop, train and manage internal staff as appropriate.
  • Fosters a commitment to quality in individuals and a culture of quality within the organization.
  • Review and advise on business area SOPs for fitness for purpose and for compliance with regulatory requirements.
  • Lead intra or interdepartmental teams of an operational nature such as preparing Gilead minor changes in regulations, and continuous improvement initiatives.


Qualifications
  • BA or BS and 10-12+ years of relevant experience (10+ years of relevant experience with an MS).
  • Is an expert in the principles of data integrity, 21 CFR Part 11 as it applies to predicate rules
  • Significant experience working to or advising business on GCP regulations and ICH E6 R2 guidance
  • Preferred experience working in data sciences or advising data sciences teams
  • Must have experience advising business in a compliance related role/ auditing experience.
  • Bio-pharma sponsor experience required.
  • Basic understanding of Laboratory and GLP systems regulatory requirements preferred.
  • Is a strategic problem solver with a deep understanding of the pharmaceutical industry
  • Exceptional verbal, written, interpersonal skills to include delivering presentations to senior leaders of the organization
  • Experience with audit management/CAPA management programs preferred
  • Excellent organization and project management skills
  • Collaborates clearly and effectively across stakeholder groups and FAs
  • Ability to travel approximately 10% required.


About Gilead R&D Quality and Medical Governance

Gilead R&D Quality and Medical Governance is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team.

We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.

We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.

Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?

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.

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. 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 ‘EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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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:

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Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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