VP GMP Clinical Manufacturing Operations

Position Summary

As VP, Global GMP Clinical Manufacturing Operations, you will lead the Medicines Global Clinical Manufacturing Operations function, ensuring the on time scale-up, manufacture, and supply of high-quality, fit-for-purpose, GMP-compliant products for clinical trials in a disciplined and compliant environment. You will play a critical role in ensuring patient safety, clinical data integrity, and delivery of R&D objectives.

You will be responsible for driving innovation and modernisation across GMP Manufacturing Operations, building on a strong foundation of operational excellence while ensuring the function remains positioned to support the evolving needs of the R&D portfolio. Reporting to the SVP, Global Clinical Manufacturing and Supply Chain (CMSC) within DDS, you will serve as a member of the CMSC Leadership Team.

You will provide leadership across six manufacturing locations: UK (Ware), USA (Upper Merion 38, Upper Merion 29, Marietta), Italy (Parma), Singapore (Jurong).

Organization Responsibilities

• Drug Substance pilot plant operations
• Drug Product pilot plant operations (OSD and Steriles)
• Manufacturing automation
• Oversight of major capital projects, including the Marietta Steriles Facility, UM Biologics Flex Factory, and Jurong Oligonucleotides Facility

Key Responsibilities

• Line leadership of global department of ca 300 scientists, engineering, process technicians and manufacturing experts across 6 sites across 4 countries, including 6 nodes/Pilot Plants, and a total budget of >£100M
• Leading the global medicines GMP Operations; accountable for the on time scale up, manufacture and supply to R&D GSK sponsored clinical trials, delivering high quality, GMP compliant drug substance, drug product across all modalities
• Accountability for the implementation of the functional strategy including modernisation and delivery of the optimised operation ready to support with flexibility the cross-modality R&D Portfolio
• Driving the comprehensive modernization/digitalisation programme as part of deployment of CMC Digital Strategy & CMC Acceleration goals
• Oversight and expert input into the design and building of the new GMP pilot plants being built at Marietta and UM Flex factory
• Monitoring the external CMO landscape and assess advances in manufacturing technologies to identify opportunities to strengthen the competitiveness of internal manufacturing operations
• Accountability for delivering technical investment proposals with clear recommendations to relevant R&D and/or CMC Governance Board(s); leading and influencing direction at senior forums
• Regularly reviewing and implementing technologies and ways of working to identify improvements in quality and efficiency
• Leader of leaders embracing and drives inclusion to create a modern and dynamic working environment across the global function
• Developing and implementing a strategic work force plan and a talented and diverse succession pool aligned to future needs
• Measuring performance and driving a customer focused, metrics driven, performance management system
• Leading significant change programmes in the department through exceptional planning, robust engagement and communication plans, and excellence in strategy development and deployment

Basic Qualifications

• Master’s degree in Chemical Engineering, Process Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or a related scientific discipline
• 10+ years experience in large pharmaceutical or biotechnology, including experience leading GMP manufacturing operations
• Experience in cross-modality drug development/manufacturing across all CMC activities
• Experience of highly regulated GMP processes necessary to develop a medicine/vaccine ready for commercial release and supply to the clinic
• Line leadership of a global scientific/technical function with significant budget responsibility (>£100s M)
• Oversight/experience of multi-year capital investment projects (over £100M)
• Experience leading organisational change initiatives and/or technology deployment programmes

Preferred Qualifications

• PhD in Engineering or a related scientific discipline
• Experience leading leaders within a complex matrix organisation, including influencing at senior level meetings, governance boards and executive forums
• Experience across multiple pharmaceutical modalities
• Demonstrated ability to communicate effectively and influence key stakeholders at all levels, both internally and externally
• Expansive and visionary thinker, with demonstrated ability to develop strategic partnerships
• Deep appreciation of the complexity and interdependency of development activities necessary to create a product and a commercially viable manufacturing process
• Understanding of the key risks and failure modes associated with pharmaceutical development and clinical supply
• Deep and rich appreciation of interdependencies with Quality, Regulatory and Technical disciplines, standards, and performance
• Interpersonal and communication skills to rapidly build trust with external and internal partners