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.

• 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.

• 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 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.

• 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.

• 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…