Senior Director, GMP Quality Assurance

Purpose

Provide strategic and enterprise-level leadership of GMP Quality and Quality across GxP domains, through oversight of a robust and integrated Quality Management System (QMS).

Strategic Quality Leadership

• Serve as a key member of the Quality Leadership Team, providing strategic direction across GMP Quality and QMS.
• Act as the executive sponsor for Quality Systems, ensuring alignment with corporate strategy and regulatory expectations.
• Present GMP and QMS performance, trends, and risks to executive leadership, including KPIs and health metrics.

Cross-Functional & Enterprise Integration

• Partner with Pharmaceutical Science (CMC), Regulatory IT, and Clinical Quality to ensure QMS integration across GxP domains.
• Collaborate with IT to implement and optimize digital QMS solutions.
• Ensure alignment between vendor quality systems and internal QMS expectations.

Strategic GMP Quality Leadership

• 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.
• Collaborate cross-functionally 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’s capabilities meet Karyopharm’s core values and future needs.
• Support development opportunities and mentor and coach team members.
• Lead and oversee writing/revising Quality SOP’s and performing review and approval of external and internal generated documents/reports (Master Batch Records, Executed BR’s, 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 into 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 manager 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.
• Demonstrated experience leading and hosting GMP audits, including health authority inspections.
• Lead and provide oversight on all Global Partnership/Alliance projects.

Quality Systems (QMS) Leadership

• Own and lead the end-to-end Quality Management System (QMS), ensuring it is compliant, scalable, and aligned with global regulatory expectations (FDA, EMA, ICH).
• Establish and maintain governance of core QMS elements, including: Deviations, CAPA, Change Control, Document Control and Records Management, Training and Learning Management Systems, Complaint Handling and Product Quality Reviews (PQR/APR).
• Drive harmonization and standardization of QMS processes across GMP and GxP functions.
• Lead QMS maturity initiatives, including continuous improvement, simplification, and digital transformation (eQMS – Veeva Quality platforms).
• Ensure inspection readiness at all times, including development of global inspection readiness frameworks, playbooks, and mock inspection programs.
• Oversee quality risk management (QRM) processes and ensure integration into QMS decision-making.
• Author, review, and/or approve documents including deviations, SOPs, and protocols.

Audit, Inspection & Compliance

• Oversee global audit and inspection strategy, integrating QMS and GMP compliance.
• In collaboration with other GxP areas, support regulatory inspections (FDA, EMA, global agencies).
• Ensure audit and inspection findings are systematically trended within the QMS to drive systemic improvements.
• Escalate critical compliance risks to executive leadership.

People & Organizational Leadership

• Lead and provide oversight of GMP & QMS teams and facilitate development opportunities and mentor and coach QA team members.
• Build and lead a high-performing GMP and QMS organization.
• Develop future leaders in both operational quality and quality systems disciplines.
• Foster a quality culture focused on compliance, accountability, and continuous improvement.