VP GMP Clinical Manufacturing Operations

GSK•Upper Providence, PA

16h

About The Position

The VP, Global GMP Clinical Manufacturing Operations leads GSK’s Medicines Global Clinical Manufacturing Operations function. The role ensures the timely scale-up, manufacture, and supply of high-quality, fit-for-purpose, GMP-compliant products for clinical trials, supporting patient safety, clinical data integrity, and R&D objectives. It is responsible for delivering clinical trial supply and transferring Drug Substance and Drug Product processes across modalities to GSK Supply Chain (GSC) and/or external manufacturing partners. The position drives innovation and modernization of GMP Manufacturing Operations and leads the function’s strategy and operational readiness to support the evolving R&D portfolio. The VP leads approximately 300 scientists, engineers, process technicians, and manufacturing experts across six locations in four countries, with a total budget exceeding £100M. The organization oversees Drug Substance and Drug Product pilot plant operations, including oral solid dose (OSD) and sterile products, manufacturing automation, and major capital projects. Reporting to the SVP, Global Clinical Manufacturing and Supply Chain (CMSC) within DDS, the VP is a member of the CMSC Leadership Team. The role collaborates with senior leaders across DDS, GSC, Finance, Quality, Regulatory, and Technical functions and represents DDS and CMSC in senior cross-functional, governance, and external forums as required. Manufacturing locations are Ware in the UK; Upper Merion (38 and 29) and Marietta in the USA; Parma in Italy; and Jurong in Singapore.

Requirements

Master’s degree in Chemical Engineering, Process Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or a related scientific discipline.
At least 10 years of experience in large pharmaceutical or biotechnology organizations, including experience leading GMP manufacturing operations.
Experience in cross-modality drug development and manufacturing across CMC activities.
Experience with highly regulated GMP processes needed to develop medicines or vaccines for commercial release and clinical supply.
Experience leading a global scientific or technical function with significant budget responsibility (stated as >£100s M).
Oversight or experience of multi-year capital investment projects valued at over £100M.
Experience leading organizational change initiatives and/or technology deployment programmes.

Nice To Haves

PhD in Engineering or a related scientific discipline.
Experience leading leaders in a complex matrix organization, including influencing senior meetings, governance boards, and executive forums.
Experience across multiple pharmaceutical modalities.
Demonstrated ability to communicate effectively and influence internal and external stakeholders at all levels.
Visionary, expansive thinking and demonstrated ability to develop strategic partnerships.
Strong understanding of the complexity and interdependency of development activities required to create a product and commercially viable manufacturing process and deliver clinical supplies.
Understanding of key risks and failure modes in pharmaceutical development and clinical supply, including how to identify, discuss, and monitor them.
Deep understanding of interdependencies with Quality, Regulatory, and Technical disciplines, standards, and performance expectations.
Interpersonal and communication skills to build trust rapidly with internal and external partners and handle difficult decisions professionally while protecting GSK’s reputation.

Responsibilities

Lead the global Medicines GMP Operations function and a department of approximately 300 people across six sites in four countries.
Ensure timely scale-up, manufacture, and supply of high-quality, GMP-compliant Drug Substance and Drug Product for GSK-sponsored clinical trials across modalities, in line with R&D objectives and applicable regulations and policies.
Implement the functional strategy, modernizing and optimizing operations to flexibly support the cross-modality R&D portfolio.
Lead the modernization and digitalization programme in support of the CMC Digital Strategy and CMC Acceleration goals.
Provide oversight and expert input into the design and construction of new GMP pilot plants at Marietta and the Upper Merion Flex Factory.
Oversee major capital projects, including the Marietta Steriles Facility, UM Biologics Flex Factory, and Jurong Oligonucleotides Facility.
Monitor external contract manufacturing organizations and manufacturing technology advances to identify opportunities to strengthen internal manufacturing operations.
Develop and present technical investment proposals to relevant R&D and CMC governance boards, and influence decisions at senior forums.
Review and implement technologies and ways of working to improve quality and efficiency; develop clear manufacturing technology investment plans across the pilot plant network with GSC partners and/or external providers.
Lead leaders and foster an inclusive, modern, dynamic working environment across the global function.
Develop and implement a strategic workforce plan and a diverse succession pool aligned with future needs, including external capabilities and collaborations.
Measure performance and drive a customer-focused, metrics-driven performance management system.
Lead significant departmental change programmes through planning, engagement, communication, and strategy development and deployment.