Senior Director, Quality Assurance- Biologics

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 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 leveraging digital tools and analytics per our Quality digital roadmaps. Builds high performing QA teams and partners closely with QC 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. Master’s degree with 12+ years of experience in biopharmaceutical or pharmaceutical quality control. Bachelor’s degree with 14+ years of experience in biopharmaceutical or pharmaceutical quality control. Associate degree with 16+ years of experience in biopharmaceutical or pharmaceutical quality control. High School Diploma / GED with 18+ years of experience in biopharmaceutical or pharmaceutical quality control. Preferred Qualifications 10+ years of experience in biopharmaceutical or pharmaceutical quality control. 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. Shows excellent verbal and written communication skills and collaborative interpersonal 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. 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). 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. Gilead Core Values Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) 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. 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.* For additional benefits information, visit: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. 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 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. Please apply via the Internal Career Opportunities portal in Workday. #J-18808-Ljbffr