Senior Director, Quality Assurance- Biologics

Senior Director, Quality Assurance
- Biologics

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 (jurisdiction control, cross input integration), 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 (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.

• 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. Stays ahead of shifting trends in industry.
• 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…