Senior Director, GMP Quality Assurance

Karyopharm Therapeutics•Newton, MA

About The Position

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. This role involves serving as a key member of the Quality Leadership Team, acting as the executive sponsor for Quality Systems, and presenting GMP and QMS performance to executive leadership. The position also requires partnering with various departments like Pharmaceutical Science (CMC), Regulatory IT, and Clinical Quality to ensure QMS integration across GxP domains, collaborating with IT for digital QMS solutions, and ensuring alignment with vendor quality systems. The role is strategic in representing the oversight and management of the GMP Quality team to support clinical and commercial manufacturing and supply, providing expertise in GMP compliance, and leading the team by planning, developing, and attracting talent. Responsibilities include overseeing the writing/revising of Quality SOPs, performing reviews and approvals of various GXP documents, leading the implementation of a robust Vendor Oversight Program, ensuring the generation and maintenance of Quality Technical Agreements, leading risk-based GMP audit and compliance strategies, assessing audit findings, leading investigations into quality issues, and overseeing Quality Management Reviews (QMRs) for GMP Quality Metrics. The role also involves leading and hosting GMP audits and health authority inspections, and overseeing Global Partnership/Alliance projects. Additionally, the role owns and leads the end-to-end Quality Management System (QMS), establishing and maintaining governance of core QMS elements, driving harmonization and standardization of QMS processes, leading QMS maturity initiatives including digital transformation, and ensuring inspection readiness. The role supports regulatory inspections and escalates critical compliance risks to executive leadership. People and organizational leadership includes overseeing GMP & QMS teams, fostering a quality culture, and developing future leaders.

Requirements

15+ years in GxP Quality, with significant leadership experience in both GMP Quality Operations and Quality Systems (QMS).
In-depth knowledge of other international regulations and guidelines related to GMP projects.
Proven experience designing, implementing, or transforming enterprise QMS frameworks.
Strong track record with regulatory inspections and global health authority interactions.
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 managing, hosting, or supporting FDA, EMA or other regulatory agency inspections.
BA/BS degree or in a life science discipline.

Nice To Haves

Experience in leading inspection readiness exercises and supporting health authority inspections is preferred.
Advanced degree is strongly preferred.
Relevant certifications are desirable but not mandatory.
Experience with small molecules is highly preferred.

Responsibilities

Provide strategic and enterprise-level leadership of GMP Quality and Quality across GxP domains.
Oversee 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.
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.
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.
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 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’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 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.
Lead and host GMP audits, including health authority inspections.
Lead and provide oversight on all Global Partnership/Alliance projects.
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 approval documents including deviations, SOPs, and protocols.
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.
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.