Description
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives.
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.
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 according to R&D objectives and compliance with all internal and external regulations and policies governing clinical supply chain.
- 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 (major capital projects).
- Monitoring the external CMO landscape and assessing 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, ensuring clear investment plans for manufacturing technologies across the pilot plant network in alignment with partners in GSC; and/or external providers.
- Leader of leaders, embracing and driving inclusion to create a modern and dynamic working environment across the global function, where people thrive.
- Developing and implementing a strategic workforce plan and a talented and diverse succession pool that is aligned to future needs, reflecting a diverse and highly skilled workforce, and incorporating external capability/collaborations.
- 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 of 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 (>£100M).
- Oversight/experience of multi-year capital investment projects (over £100M).
- Experience leading organisational change initiatives and/or technology deployment programmes.
Benefits:
- Comprehensive benefits program, including details available on GSK US Benefits Summary