New · posted Nov 11
Gilead Sciences · Biotechnology
Senior Manager, Quality Assurance
- Foster City, CA
- On-site
- Full-time
- Manager
The role
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will report to the Associate Director, Quality Assurance within the PDM External Quality organization. This position is dedicated to managing and supporting the Gilead Global Quality Agreement Program.
This position will have high visibility throughout the PDM organization as the Global Process Owner (GPO) for Gilead’s Global Quality Agreement Program and will collaborate with key internal partners & stakeholders to establish and maintain an effective Global Quality Agreement Program. This position will serve as the primary subject matter expert (SME) for matters related to Quality Agreement content, Quality Agreement lifecycle management, Quality Agreement negotiations, management of Quality Agreement templates in compliance with applicable laws and regulatory requirements, and supporting continuous improvement initiatives related to the Global Quality Agreement Program.
What you need
3 ways to qualify
Bachelor’s
+ 8+ years of experience
8+ years of relevant experience in a GMP environment related field and a BS or BA OR
- or
Master’s
+ 6+ years of experience
6+ years of relevant experience in a GMP environment related field and a MA/MS OR
- or
PhD
+ 2+ years of experience
2+ years of relevant experience in a GMP environment related field and a PhD/PharmD
People Leader Accountabilities
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $157,590.00 - $203,940.00. 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*.
Preferred Knowledgenice to have
- Experience working with and managing relationships with Contract Manufacturing Organizations (CMOs) and other external partners is preferred
- Experience interacting with regulatory authorities and supporting inspections related to Quality Agreements or external quality oversight is beneficial and preferred
- Experience managing global programs or serving as a Global Process Owner (GPO) is beneficial
- Familiarity with digital tools or systems supporting document management, contract lifecycle management, or Quality Agreement tracking is beneficial
- Experience and working knowledge with digital Quality Management Systems and Quality Document Management Systems, particularly Veeva Vault, is beneficial..
What you'll do
- Serves as the Global Process Owner (GPO) for Gilead’s Global Quality Agreement Program, ensuring the program is compliant, consistent, and effectively implemented across the organization
- Develops, maintains, and continuously improves standardized Quality Agreement templates, guidance documents, training materials, and related tools to align with global regulatory requirements and internal policies
- Serves as the primary subject matter expert (SME) for Quality Agreement content, interpretation, and applicability across internal teams and external partners, which may include supporting internal stakeholders during review, negotiation, implementation, enforcement, and periodic review of Quality Agreements.
- Drives alignment and resolution of complex Quality Agreement terms through collaboration with Legal, Sourcing, and External Quality stakeholders
- Establishes and maintains governance processes, metrics, and reporting for the Global Quality Agreement Program to ensure transparency and effectiveness
- Monitors regulatory trends and evolving expectations related to Quality Agreements and proactively updates program requirements and templates accordingly
- Provides expert support during inspections and audits related to Quality Agreements, including preparation, defense, and remediation activities
- Leads or contributes to continuous improvement initiatives to enhance Quality Agreement processes, reduce cycle times, and improve compliance and user experience
- Supports training and knowledge-sharing activities to ensure consistent understanding and application of Quality Agreement requirements across the organization
The best candidate...
- Demonstrates expertise in Quality Agreements, including development, negotiation, lifecycle management, and governance in a global GMP environment
- Demonstrates strong working knowledge of global regulatory requirements applicable to Quality Agreements (e.g., FDA, EMA, ICH) and ability to translate requirements into compliant contract content
- Demonstrates strong technical writing skills with the ability to draft, review, and standardize Quality Agreement templates and supporting documentation
- Demonstrates advanced stakeholder management, influencing, and negotiation skills across cross-functional and external partner environments
- Demonstrates ability to manage and support complex, high-visibility programs with multiple concurrent deliverables and competing priorities
- Demonstrates strong communication skills, including the ability to clearly articulate Quality Agreement expectations to internal stakeholders and external partners
- Demonstrates the ability to learn quickly and operate effectively in a fast-paced, highly regulated environment
Pay
$157,590 – $203,940 a year
Employer providedFor additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Where you'll work
Foster City, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Foster City, CAWorking conditions
For Current Gilead Employees and Contractors
Please apply via the Internal Career Opportunities portal in Workday.
Equal opportunity, accessibility and legal noticesGilead Sciences's statements, word for word
For jobs in the United States
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 [email protected] for assistance.
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
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 26% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in California9 roles publishing pay
Manager roles in the US58 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $157,590 | — | $203,940 |
| California (middle half) | $149,000 | $157,500 | $181,000 |
| All US (middle half) | $116,375 | $143,750 | $163,250 |
This role: Gilead Sciences's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 340 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Gilead's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership19
- GMP and compliance8
- Documentation and SOPs5
- Quality systems and risk3
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality AgreementsNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
Company hiring pulse
Gilead on Regulatory Jobs
- 93
- Open roles
- 93
- Distinct roles
- 8
- Locations
By discipline
- Quality54 53%
- Clinical31 30%
- Regulatory17 17%
By level
- Director56 55%
- Manager20 20%
- Senior & Principal15 15%
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Senior Manager, Quality Assurance at Gilead
Open until filled. $158K–$204K a year, employer provided.