Senior Director — Quality Assurance Head, Molecules

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.

• 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 (jurisdiction control, cross input integration), leveraging digital tools and analytics per our Quality digital roadmaps.
• Cross-Functional Collaboration:
  
  Builds high performing QA teams and partners 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.

• Required:
  
  PhD or Pharm
  
  D with 12+ years of experience
• Required:
  
  MS with 12+ years of experience
• Required:
  
  BS with 14+ years of experience
• Preferred: 12+ years’ experience in Biopharmaceutical or Pharmaceutical manufacturing quality assurance and quality control
• Preferred: 5+ years of people leadership experience

• Strong verbal and written communication; collaborative interpersonal skills
• Excellent influencing and leadership skills; ability to work with senior executives
• Critical and creative thinking; independent resource management
• Organizational and planning proficiency; ability to drive cross-functional initiatives
• Deep understanding of GMP principles and quality principles in US and international contexts
• Ability to leverage digital tools and analytics for quality decision-making

• PhD or Pharm
  
  D; or MS; or BS with extensive relevant experience as listed above