Senior Director, Quality Assurance- Biologics

Role Summary

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.

Responsibilities

• 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.
• Quality Leadership & Strategy: 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).
• Quality Leadership & Strategy: Hands-on leadership ensuring QA responsibilities are executed: complaints handling, investigations, escalation of serious GMP issues, internal audits/self-inspection, and training effectiveness.
• Quality Leadership & Strategy: Demonstrated leadership of batch release decisioning (jurisdiction control, cross input integration), 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.
• Compliance & Regulatory Affairs: Comfortable representing the company to health authorities; able to navigate challenging audit situations.
• Operational Oversight: Oversee Quality Assurance (QA) and Compliance functions.
• Operational Oversight: Ensure timely release of products, materials, and batches in accordance with quality standards.
• Operational Oversight: Champion continuous improvement to reduce deviations and cycle times, and to improve CAPA effectiveness and audit readiness.
• Operational Oversight: Identify and manage quality risks across the product lifecycle and implement mitigation strategies.
• Operational Oversight: Acts as an escalation point for complex/high impact quality issues and decisions.
• People & Culture: Lead, mentor, and develop a high-performing quality team.
• People & Culture: 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.
• Cross-Functional Collaboration: Build high performing QA teams and partner closely with QC (clear QA vs. QC accountability split) to ensure technical rigor and compliance.
• Cross-Functional Collaboration: Represent Quality Assurance in site leadership forums and strategic initiatives.

Qualifications

• Required: Doctorate degree with 12+ years of experience in Biopharmaceutical or Pharmaceutical quality control
• Required: Master’s degree with 12+ years of experience in Biopharmaceutical or Pharmaceutical quality control
• Required: Bachelor’s degree with 14+ years of experience in Biopharmaceutical or Pharmaceutical quality control
• Required: Associate degree with 16+ years of experience in Biopharmaceutical or Pharmaceutical quality control
• Required: High School Diploma / GED with 18+ years of experience in Biopharmaceutical or Pharmaceutical quality control
• Preferred: 10+ years of experience in Biopharmaceutical or Pharmaceutical quality control; stays ahead of shifting trends in the industry
• Preferred: 5+ years of prior senior leadership experience
• Preferred: Strong analytical, critical thinking, and problem-solving abilities; ability to work independently and determine appropriate resources for resolution
• Preferred: Strong organizational and planning skills; excellent verbal and written communication and collaborative interpersonal skills
• Preferred: Experience across a broad set of Quality Assurance sub-functions with knowledge of industry best practices and trends
• Preferred: Ability to establish credibility with diverse audiences and demonstrate leadership; excellent influencing skills
• Preferred: Deep understanding of business objectives and how they translate into quality priorities; ability to work with senior executives
• Preferred: Judgment and independent action where precedents may not exist; deep understanding of GMP principles (US and international)
• Preferred: Ability to develop and improve complex concepts, techniques, standards and new applications based on quality principles
• Preferred: GMP manufacturing oversight with biologics manufacturing experience (cell culture, purification, and/or fill finish); knowledge of medical devices and combination products is a plus
• Preferred: Proven ability to develop a vision for Quality Assurance functions and build the function to fulfill that vision
• Preferred: Strong hiring and staff development skills; ability to motivate and engage individuals

Education

• Doctorate, or Master’s, or Bachelor’s, or Associate, or High School Diploma with relevant years of Biopharmaceutical/Pharmaceutical quality control experience as specified above