Senior Director, Quality Assurance- Biologics

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.

Basic Qualifications:

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