Gilead Sciences · 17 hours ago
Sr Director, Quality Control
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$243K/yr - $315K/yr
12+ years expGilead Sciences is dedicated to creating a healthier world and tackling significant health challenges through innovative therapies. The Senior Director of Quality Control will provide strategic leadership for Clinical Biologics QC, overseeing the release testing and stability program while ensuring compliance with global cGMP standards and fostering a culture of continuous improvement.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Oversee the development and implementation of end-to-end Clinical Quality Control strategy for Gilead’s portfolio of biologics products
Have ultimate responsibility for staff development, and contribute to budgeting, cost control, and strategic planning of the Biologics Quality Control department. Provide leadership and guidance to direct reports and project team members to develop strong leaders at Gilead
Lead, motivate, and develop the team, routinely making decisions to ensure project timelines are met
Ensure that Quality Control Systems and practices are developed and implemented internally and externally at contract manufacturing sites and contract laboratories for Clinical biologics
Demonstrate a clear understanding of biological product testing methods and assays for effective troubleshooting, and remediation of atypical results. Act as an escalation point for complex/high impact quality control issues/decisions
Support identification, evaluation, selection, and management CMOs/CTLs, consultants etc. to control quality in support of achieving PDM’s strategic objectives. Establish clear expectations, metrics and KPIs, as appropriate to monitor QC operations and analytical method performance
Be accountable for reviewing data and troubleshooting analytical testing within the Biologics portfolio across internal and external partners. Monitor test method execution in QC laboratories to ensure methods are in a continuous state of control
Support validation of analytical methods for new Biologics programs and their transfer to outsourced partners to meet GMP testing needs
Contribute to Regulatory Filings, and responses to Information Requests from Regulatory Agencies
Interface with Regulatory agencies as required representing Gilead to authorities and regulatory inspectorates in matters relating to QC operations and stability studies
Lead or serve as a key project team member on large cross functional projects, often with high visibility to senior management within the organization or with international impact
Provide a long-term view to senior QC Leadership based on personal knowledge of the competitive environment
Support standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Control Systems
Qualification
Required
Experience over a broad set of Quality Control sub-functions with extensive knowledge of industry best practices and trends
In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally
Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories
Must be able to develop solutions to complex problems, which require a high degree of ingenuity and creativity
Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist
Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions
Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision
Demonstrated experience and ability to manage and lead staff, with strong hiring and staff development skills, and the ability to motivate and engage individuals
Demonstrated the ability to influence process and outcomes across functions
Experience with QC systems such as EDMS and LIMS
14+ years' experience with a BS OR 12+ years' experience with a MS degree in related fields
Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting trends in industry
Prior senior leadership experience required
Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems
Strong organizational and planning skills
Shows excellent verbal and written communication skills and collaborative interpersonal skills
Preferred
An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable
Benefits
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-16
FierceBiotech
2026-01-16
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