Senior Director — Quality Assurance Head, Small Molecules
Scorpion Therapeutics, San Francisco
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 (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.
Qualifications
- Required: PhD or PharmD 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
Skills
- 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
Education
- PhD or PharmD; or MS; or BS with extensive relevant experience as listed above