Executive Director Quality Systems & Compliance

Role Summary

Executive Director, Cell Therapy Quality Compliance, leads global cell therapy quality compliance programs across development and commercial operations. Responsible for implementing and continuously improving compliance with global regulations and internal standards, partnering with cross-functional teams, and guiding a global quality compliance team to ensure readiness and adherence across the cell therapy network.

Responsibilities

• Partner with Cell Therapy Development, Operations, and Franchise organizations, as well as matrix teams, to ensure alignment with annual compliance objectives and clearly defined roles and responsibilities.
• Lead the team of Cell Therapy local Process Owners in maintaining and enforcing Governance Controls for processes, including Management Responsibility, Event Management, Change Management, and Quality Risk Management, with a primary focus on regulatory compliance. Oversee Disposition (including ERP Quality system requirements) and Field Action processes to ensure strict adherence to compliance standards.
• Provide end-to-end oversight of Cell Therapy post-market compliance activities, including ownership of the Product Complaints Program for investigational and commercial complaints in all markets, ensuring timely and compliant resolution in accordance with regulatory requirements.
• Serve as the Cell Therapy compliance lead for ongoing oversight and guidance on QMS implementation and continuous improvement to ensure compliance across Cell Therapy Development, Operations, and Franchise.
• Own and manage the Cell Therapy Material Review Board program, ensuring compliant handling of non-conforming products for clinical and commercial patients, including the development and maintenance of communication templates, documents, and forms for regulatory and treatment site interactions.
• Oversee the Cell Therapy management process for manufacturing IP documentation and processes, ensuring compliance with regulatory requirements. Serve as the Cell Therapy compliance lead during GCP inspections, providing expertise and support for manufacturing IP documentation.
• Represent Cell Therapy Quality Compliance at forums and governance committees for Cell Therapy Development and Operations, Clinical Quality, Medical Affairs, and GPS, advocating for compliance best practices and regulatory adherence.
• Chair the governance of the Cell Therapy Development, Operations, and Franchise Quality Compliance Roadmap in collaboration with IT, ensuring compliance objectives are integrated into strategic planning.
• Collaborate with Cell Therapy Internal and External Manufacturing Quality teams and Clinical Quality to strategically prepare for and manage regulatory inspections, applying principles of Quality Risk Management to ensure inspection readiness and compliance. Assist in the review and preparation of written responses to regulatory inspection observations and health authority reports, ensuring accuracy and compliance.
• Oversee Global CT quality and compliance metrics for Cell Therapy Development, Operations, and Franchise, ensuring ongoing monitoring and reporting to maintain regulatory compliance.
• Work collaboratively with Global Quality Governance and Performance Management Leaders to refine, monitor, and report on quality and compliance operational performance indicators for Cell Therapy. Periodically review compliance and quality metrics across the Cell Therapy network to proactively identify emerging trends, develop and implement action plans, and ensure continuous improvement and sustained compliance.
• In partnership with Global Quality Governance and Performance Management Leaders, Cell Therapy Internal Manufacturing, and External Manufacturing, review all Notifications to Management across the Cell Therapy network to proactively identify compliance risks and trends, and implement appropriate corrective actions to maintain and enhance compliance.

Qualifications

• Advanced degree in life sciences, manufacturing or related discipline preferred.
• Minimum of 15 years of quality experience for biopharmaceuticals in clinical and/or commercial manufacturing environments. Cell therapy experience preferred.
• Expertise in GMP compliance, global regulations and strong understanding of quality management systems is required.
• Demonstrated decision making and problem-solving capabilities relative to Quality, Compliance, and regulatory requirements are required.
• Ability to identify and implement phase-appropriate compliance strategies to support the end to end product lifecycle.
• Demonstrated ability to apply effective risk management approaches that provide a proactive means of identification and control of potential quality issues.
• Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders from Cell Therapy Franchise, Cell Therapy Development and Operations, GDD and GPS in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on behalf of the VP of Cell Therapy Quality to interface with stakeholders in a matrix environment.
• Experience leading a large, diverse, geographically dispersed group of colleagues.
• Ability to build strong, trusting relationships, lead large/complex teams, and work across divisions, diverse business backgrounds and cultures.
• Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
• Experience in Cell Therapy (preferred), Biologics and Sterile manufacturing.
• Strong and demonstrated strategic thinking capability with strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk.
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
• Ability to provide innovative ideas and risk-based alternatives that create value including seeking new information and external insights without compromising compliance.

Education

• Advanced degree in life sciences, manufacturing or related discipline preferred.

Additional Requirements

• Travel: This position requires travel. Estimated to be approx. 25%.