Executive​/Senior Director, Gmp Quality & Quality Management System; Qms

Role Overview & Key Functions:

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). Lead a team of subject matter experts to ensure the design, implementation, and continuous improvement of quality systems that enable compliant clinical development, pharmacovigilance, and manufacturing operations across the product lifecycle.

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.
• Collaborates 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 value 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  ’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,…