Senior Director — Quality Assurance Head, Small Molecules
Scorpion Therapeutics, San Francisco, California, United States, 94199
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
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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
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