Exec Director, Quality

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
 

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. 

TITLE: 

Executive Director — Biologics Quality Control (Grade 34) 

KEY RESPONSIBILITIES: 

 
The Executive Director, Site Quality Head is responsible for leading all Quality functions at the pharmaceutical manufacturing site, ensuring compliance with global regulatory standards, driving a culture of quality and continuous improvement, and serving as the primary quality authority for the site. This role is accountable for the strategic direction, operational execution, and leadership of Quality Assurance, Quality Control, and Compliance teams. 

FOCUS AREAS 

Quality Leadership & Strategy 

• Develop and execute the site’s quality strategy aligned with corporate objectives and regulatory expectations. 

• Serve as the site’s quality representative to global quality leadership and regulatory agencies. 

Compliance & Regulatory Affairs 

• Ensure site-wide compliance with cGMP, FDA, EMA, ICH, and other applicable regulations. 

• Lead regulatory inspections and audits, including preparation, hosting, and response management. 

Operational Oversight 

• Oversee Quality Assurance (QA), Quality Control (QC), and Compliance functions. 

• Ensure timely release of products, materials, and batches in accordance with quality standards. 

People & Culture 

• Lead, mentor, and develop a high-performing quality team. 

• Foster a culture of accountability, transparency, and continuous improvement. 

Risk Management & Decision-Making 

• Serve as the final quality decision-maker for critical quality issues, deviations, and product disposition. 

• Lead risk assessments and implement mitigation strategies. 

Cross-Functional Collaboration 

• Partner with Manufacturing, Supply Chain, Technical Development to ensure quality is embedded across all site operations. 

• Represent Quality in site leadership forums and strategic initiatives. 

REQUIREMENTS 

You have: 

• Experience over a broad set of Quality 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.  

• 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 precedent 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, and standards and new applications based on quality principles and theories.  

• Demonstrated an ability to develop a vision for Quality functions and have shaped the capabilities of the function to fulfill that vision.  

• Strong hiring and staff development skills, with the ability to motivate and engage individuals.  

QUALIFICATIONS:  

• 16+ years’ experience with a BS OR 14 Years’ experience with a MS, MBA, PHD or PharmD in a related field OR 8+ years’ experience with an MD degree in related field 

• Prior experience in a Quality Assurance (QA) role, with a solid understanding of QA principles and practices.

• Extensive 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. 

Gilead Core Values  

Integrity (Doing What’s Right)  

Inclusion (Encouraging Diversity)  

Teamwork (Working Together)  

Excellence (Being Your Best)  

Accountability (Taking Personal Responsibility) 

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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. 

Please apply via the Internal Career Opportunities portal in Workday.