Senior Director — Quality Assurance Head, Small Molecules

Senior Director — Quality Assurance Head, Small Molecules

Join Gilead Sciences to lead our independent Quality Assurance organization, responsible for a risk‑based Pharmaceutical Quality System (PQS), final batch disposition, inspection performance, and a culture of continuous improvement and data integrity.

Job Description

The Senior Director, Quality Assurance partners with Site and global Quality leaders to assure supply, quality, and compliance. The role drives strategic quality initiatives and provides independent oversight of manufacturing and testing activities.

Focus Areas

Quality Leadership & Strategy

Own the site PQS aligned to our Quality Manual, overseeing policy, CAPA / change control, data integrity, risk-based approaches and periodic management reviews.

Run an independent QA function with authority for final batch disposition and QA oversight of manufacturing / testing, ensuring independence from production.

Lead the execution of QA responsibilities : complaints handling, investigations, escalation of serious GMP issues, internal audits / self‑inspection, and training effectiveness.

Lead batch release decisioning, integrating cross‑functional inputs, and leverage digital tools and analytics as per our Quality digital roadmaps.

Compliance & Regulatory Affairs

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

Represent the company to health authorities, navigating challenging audit situations.

Operational Oversight

Oversee QA and Compliance functions, ensuring timely release of products and batches.

Champion continuous improvement to reduce deviations, cycle times and improve CAPA effectiveness and audit readiness.

Identify and manage quality risks across the product lifecycle and implement mitigation strategies.

Act as 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

Collaborate closely with QC to maintain clear QA vs. QC accountability and technical rigor.

Represent Quality Assurance in site leadership forums and strategic initiatives.

Lead batch release decisioning and integrate cross‑functional inputs.

Basic Qualifications

PhD / PharmD with 12+ years of experience.

OR MS with 12+ years of experience.

OR BS with 14+ years of experience.

Preferred Qualifications

12+ years’ experience in Biopharmaceutical or Pharmaceutical manufacturing quality assurance and quality control.

5+ years of people leadership experience.

Critical-thinking, creative problem‑solving, independent resource determination.

Strong organizational and planning skills.

Excellent verbal and written communication and collaboration skills.

Expertise in industry best practices and trends across QA sub‑functions.

Credibility with diverse audiences and influence at all levels.

In-depth understanding of business objectives and translation into quality priorities.

Judgement and decision‑making in ambiguous situations.

GMP principles, concepts, practices and standards in US and internationally.

Capability to develop and improve complex concepts, techniques, standards and new applications.

Knowledge of medical devices and combination products is a plus.

Vision for QA functions and capability to shape the function’s capabilities.

Strong hiring and staff development skills.

Gilead Core Values

Integrity (Doing What’s Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

Compensation & Benefits

The salary range for this position is : $243,100.00 – $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for discretionary annual bonus, discretionary stock‑based long‑term incentives, paid time off, and a benefits package including company‑sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit

https : / / www.gilead.com / careers / compensation-benefits-and-wellbeing .

Equal Opportunity Statement

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 will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, gender identity, veteran status or any other protected characteristic as required by applicable federal, state and local laws. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

#J-18808-Ljbffr