VP GMP Clinical Manufacturing Operations

GSK•Marietta, PA

12d

About The Position

The VP, Global GMP Clinical Manufacturing Operations leads GSK Medicines’ Global Clinical Manufacturing Operations function, ensuring the timely scale-up, manufacture, and supply of high-quality, fit-for-purpose, GMP-compliant products for clinical trials. The role is accountable for patient safety, clinical data integrity, and delivery of R&D objectives, including seamless support for clinical trials and successful development and transfer of Drug Substance and Drug Product processes to GSC and/or external manufacturing partners. The position leads a global department of approximately 300 scientists, engineers, process technicians, and manufacturing experts across six manufacturing locations in four countries, with six pilot plant nodes and a total budget greater than £100 million. The organization oversees Drug Substance and Drug Product pilot plant operations, including oral solid dosage and sterile products, manufacturing automation, and major capital projects such as the Marietta Steriles Facility, UM Biologics Flex Factory, and Jurong Oligonucleotides Facility. The VP drives functional strategy, operational excellence, modernization, and digitalization to ensure flexible support for the cross-modality R&D portfolio. The role reports to the SVP, Global Clinical Manufacturing and Supply Chain (CMSC) within DDS, serves on the CMSC Leadership Team, and works with senior leaders across DDS, GSC, Finance, Quality, Regulatory, and Technical functions. The VP also represents DDS and CMSC in senior cross-functional, governance, and external forums as required.

Requirements

Master’s degree in Chemical Engineering, Process Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or a related scientific discipline.
10 or more 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 a medicine or vaccine for commercial release and clinical supply.
Experience leading a global scientific or technical function with significant budget responsibility (greater than £100 million).
Experience overseeing or working with multi-year capital investment projects exceeding £100 million.
Experience leading organizational change initiatives and/or technology deployment programs.

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.
Strategic and visionary thinking, with demonstrated ability to develop strategic partnerships.
Strong understanding of the complexity and interdependence of development activities required to create a product and commercially viable manufacturing process and deliver clinical investigation 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 a global department of approximately 300 scientists, engineers, process technicians, and manufacturing experts across six sites in four countries, six pilot plant nodes, and a budget greater than £100 million.
Lead global medicines GMP operations and ensure timely scale-up, manufacture, and supply for GSK-sponsored R&D clinical trials, delivering high-quality, GMP-compliant Drug Substance and Drug Product across modalities and complying with applicable internal and external regulations and policies.
Implement the functional strategy, modernize operations, and prepare the organization to flexibly support the cross-modality R&D portfolio.
Drive the modernization and digitalization program 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 UM Flex Factory.
Monitor external contract manufacturing organization capabilities and manufacturing technology advances to identify opportunities to strengthen internal manufacturing competitiveness.
Develop technical investment proposals with clear recommendations for relevant R&D and/or CMC governance boards, and influence direction at senior forums.
Review and implement technologies and ways of working to improve quality and efficiency; establish manufacturing technology investment plans across the pilot plant network in alignment with GSC partners and/or external providers.
Lead leaders and foster an inclusive, modern working environment across the global function.
Develop and implement a strategic workforce plan and a diverse succession pool aligned to future needs, incorporating external capabilities and collaborations.
Measure performance and drive a customer-focused, metrics-driven performance management system.
Lead significant departmental change programs through planning, engagement, communication, and strategy development and deployment.
Work closely with senior leaders across DDS, GSC, Finance, Quality, Regulatory, and Technical functions, and represent DDS and CMSC in senior cross-functional, governance, and external forums as required.