Executive Director, GMP Quality Assurance

Role Summary

Executive Director, GMP Quality Assurance – The Senior Director of Quality Assurance will provide strategic and operational leadership for the quality oversight of both drug substance and drug product manufacturing, packaging, labeling and distribution and support Quality Management Systems within GMP operations. Manage activities and projects to meet company objectives including review, approval and Quality oversight of all aspects of commercial manufacturing at CDMOs, packaging and labeling, warehousing and the global distribution of commercial API and Drug Product. Responsible for ensuring all company, regional, and global standards and regulations are met, and that the department is developed and maintained to a standard that ensures the quality of products and materials produced by our contracted partners.

Responsibilities

• Strategic leader on the Quality and Compliance Leadership Team to represent the oversight and management of the GMP Quality team to support clinical and commercial manufacturing and supply.
• Provide oversight to and actively manage the GMP Quality Operations team.
• Provide expertise in GMP compliance interpretation, consultation, training, and recommendations.
• Collaborates cross-functionally with other functions, such as CMC, Regulatory, Quality Systems, Vendor Management as needed to ensure alignment and best practices.
• Lead the team by planning and developing and attracting talent and ensuring that the team‚Äôs capabilities meet Karyopharm‚Äôs core value and future needs.
• Support development opportunities and mentor and coach team members.
• Lead and oversee writing/revising Quality SOPs and performing review and approval of external and internal generated documents/reports (Master Batch Records, Executed BRs, specifications, methods, validation documents, and other GXP Documentation).
• Lead implementation of a robust Vendor Oversight Program for GMP Quality Vendors.
• Ensure generation and maintenance of Quality Technical Agreements with Contract Service Providers.
• Lead and provide oversight of GMP team and facilitate development opportunities and mentor and coach QA team members.
• Lead and provide oversight of the risk based GMP audit and compliance strategy. Lead the assessment of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Senior Management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
• Lead investigations into significant quality issues with focus on product impact and patient safety; escalate and manage MRB (Material Review Board) meetings; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
• Lead and oversee the GMP Quality Management Reviews (QMRs) as SME to GMP Quality Metrics. Analyze, report, and present metrics to functional teams and Quality management; identify any risks and recommend any required actions and monitor implementation of mitigation or preventive actions.
• Lead identification and mitigation of GMP activities and process improvement initiatives.
• Collaborate with the GxP Quality team to ensure alignment and compliance with Karyopharm‚Äôs Quality Systems and other GxP functions.
• Must be able to articulate complex issues clearly verbally and written.
• Author, review, and/or approve documents including deviations, SOPs, and protocols.
• Demonstrated experience leading and hosting GMP audits, including health authority inspections.
• Lead and provide oversight on all Global Partnership/Alliance projects.
• Extensive (minimum 15 years) experience in GMP Quality Operations in Pharma/Biotech Industry, quality management, quality assurance or compliance roles with a focus on GMP.
• In-depth knowledge of other international regulations and guidelines related to GMP projects
• Excellent understanding of the drug development and commercialization process.
• Proven track record of successful management of quality management, quality assurance and/or compliance programs, including participation in audits and/or inspections, and investigating and addressing non-compliance issues.
• Demonstrated leadership skills and experience in managing cross-functional matrixed teams.
• Strong communication and interpersonal skills, capable of effectively collaborating with cross-functional teams and external stakeholders.
• Strong problem-solving and decision-making abilities, with a focus on continuous improvement.
• Experience in leading inspection readiness exercises and supporting health authority inspections is preferred.
• Minimum BA/BS degree or in a life science discipline. Advanced degree is strongly preferred.
• Relevant certifications are desirable but not mandatory.
• Experience with small molecules is highly preferred.
• Experience in managing, hosting, or supporting FDA, EMA or other regulatory agency inspections.

Qualifications

• Extensive GMP Quality Operations experience in pharma/biotech (15+ years).
• Strong track record in audits/inspections, regulatory interactions, and CAPA leadership.
• Leadership of cross-functional teams; strategic and operational mindset.
• BA/BS in life science; advanced degree preferred; relevant certifications desirable.

Skills

• GMP regulatory knowledge
• Quality systems and documentation management
• Risk assessment and CAPA
• Audit management and inspection readiness
• Vendor management and Quality Agreements
• Root cause analysis and corrective actions
• Strong written and verbal communication

Education

• BA/BS in life science or related field; advanced degree strongly preferred.

Additional Requirements

• Experience with FDA, EMA or other regulatory agency inspections.