Senior Director, Quality Assurance- Biologics

Gilead Sciences•Foster City, CA

20h

About The Position

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 The Senior Director, Quality Assurance leads the site’s independent Quality Assurance organization, accountable for an effective, risk‑based PQS, final batch disposition, inspection performance, and a culture of continuous improvement and data integrity. Partners with the Site and global Quality leaders to assure supply and compliance. FOCUS AREAS Quality Leadership & Strategy Demonstrate ownership of a site Pharmaceutical Quality System (PQS) aligned to our Quality Manual, including policy/standards oversight, CAPA/change control governance, data integrity, risk-based approaches and periodic management reviews . Able to run an independent QA function , with authority for final batch disposition , QA oversight of manufacturing/testing, and independence from production per our GMP Quality Manuals (Gilead/Kite). Hands-on leadership ensuring QA responsibilities are executed: complaints handling, investigations, escalation of serious GMP issues, internal audits/self-inspection, and training effectiveness. Demonstrated leadership of batch release decisioning (jurisdiction control, cross input integration), leveraging digital tools and analytics per our Quality digital roadmaps Compliance & Regulatory Affairs Ensure site-wide compliance with cGMP, FDA, EMA, ICH, and other applicable regulations. Comfortable representing the company to health authorities ; able to navigate challenging audit situations—capabilities explicitly called out in our QA career paths. Operational Oversight Oversee Quality Assurance (QA) and Compliance functions. Ensure timely release of products, materials, and batches in accordance with quality standards. Champions continuous improvement to reduce deviations and cycle times, and to improve CAPA effectiveness and audit readiness Identify and manage quality risks across the product lifecycle and implement mitigation strategies Acts as an escalation point for complex/high impact quality issues and decisions People & Culture Lead, mentor, and develop a high-performing quality team. Foster a culture of accountability, transparency, and continuous improvement. Cross-Functional Collaboration Demonstrated leadership of batch release decisioning (jurisdiction control, cross input integration), leveraging digital tools and analytics per our Quality digital roadmaps Builds high performing QA teams and partners closely with QC (clear QA vs. QC accountability split) to ensure technical rigor and compliance. Represent Quality Assurance in site leadership forums and strategic initiatives.

Requirements

Doctorate degree with 12+ years of experience in Biopharmaceutical or Pharmaceutical quality control OR Master’s degree with 12+ years of experience in Biopharmaceutical or Pharmaceutical quality control OR Bachelor’s degree with 14+ years of experience in Biopharmaceutical or Pharmaceutical quality control OR Associate degree with 16+ years of experience in Biopharmaceutical or Pharmaceutical quality control OR High School Diploma / GED with 18+ years of experience in Biopharmaceutical or Pharmaceutical quality control
Shows excellent verbal and written communication skills and collaborative interpersonal skills.
Significant in-depth understanding of business objectives and how they translate into quality priorities.
Must have the experience and confidence necessary to work with senior executives, and the ability to build rapport with employees at all levels.
Must be able to exercise judgment and independently determine and take appropriate action where precedents may not exist.
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, standards and new applications based on quality principles and theories.
Provide GMP manufacturing quality oversight.
Must have biologics manufacturing experience (e.g. Biologics: cell culture, purification, and/or fill finish).

Nice To Haves

10+ years of experience in Biopharmaceutical or Pharmaceutical quality control.
Stays ahead of shifting trends in industry.
5+ years of prior senior leadership experience.
Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
Strong organizational and planning skills.
Experience over a broad set of Quality Assurance sub-functions with extensive knowledge of industry best practices and trends.
Ability to quickly establish credibility with diverse audiences and be perceived as a leader.
Excellent verbal, written, and interpersonal communication skills are required.
Must possess excellent influencing skills.
Knowledge of medical devices and combination products is preferred.
Demonstrated an ability to develop a vision for Quality Assurance functions and shaped the capabilities of the function to fulfill that vision.
Strong hiring and staff development skills, with the ability to motivate and engage individuals.

Responsibilities

Leads the site’s independent Quality Assurance organization, accountable for an effective, risk‑based PQS, final batch disposition, inspection performance, and a culture of continuous improvement and data integrity.
Partners with the Site and global Quality leaders to assure supply and compliance.
Demonstrate ownership of a site Pharmaceutical Quality System (PQS) aligned to our Quality Manual, including policy/standards oversight, CAPA/change control governance, data integrity, risk-based approaches and periodic management reviews
Run an independent QA function , with authority for final batch disposition , QA oversight of manufacturing/testing, and independence from production per our GMP Quality Manuals (Gilead/Kite).
Hands-on leadership ensuring QA responsibilities are executed: complaints handling, investigations, escalation of serious GMP issues, internal audits/self-inspection, and training effectiveness.
Demonstrated leadership of batch release decisioning (jurisdiction control, cross input integration), leveraging digital tools and analytics per our Quality digital roadmaps
Ensure site-wide compliance with cGMP, FDA, EMA, ICH, and other applicable regulations.
Comfortable representing the company to health authorities ; able to navigate challenging audit situations—capabilities explicitly called out in our QA career paths.
Oversee Quality Assurance (QA) and Compliance functions.
Ensure timely release of products, materials, and batches in accordance with quality standards.
Champions continuous improvement to reduce deviations and cycle times, and to improve CAPA effectiveness and audit readiness
Identify and manage quality risks across the product lifecycle and implement mitigation strategies
Acts as an escalation point for complex/high impact quality issues and decisions
Lead, mentor, and develop a high-performing quality team.
Foster a culture of accountability, transparency, and continuous improvement.
Demonstrated leadership of batch release decisioning (jurisdiction control, cross input integration), leveraging digital tools and analytics per our Quality digital roadmaps
Builds high performing QA teams and partners closely with QC (clear QA vs. QC accountability split) to ensure technical rigor and compliance.
Represent Quality Assurance in site leadership forums and strategic initiatives.

Benefits

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.

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