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VP, Global GMP Clinical Manufacturing Operations

Stevenage

Job Type

Job Function

Manufacturing

Location

Stevenage

On-Site or Remote

Job Type

Salary

Competitive salary and benefits

About the Role

*Job description* *Site Name:* USA - Pennsylvania - King of Prussia, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware, USA - Pennsylvania - Upper Providence *Posted Date:* Feb 2 2024 A key strategic ambition of our global Clinical Supply Chain (CSC) is to enable the delivery of our exciting multi-modality pipeline by accelerating the optimization of our internal global GMP clinical manufacturing operations network. To deliver this ambition, we are establishing a single point accountability for Clinical Manufacturing Operations delivery within CSC, driving standardization of operations, simplification of engineering and validation, and effective deployment of automation and tech transfer refreshed processes and digital tools. The newly created role of VP, Global GMP Clinical Manufacturing Operations will bring together all Pilot Plant nodes, along with manufacturing automation. In this role you will look to establish and operate a new integrated global clinical manufacturing operations organization with the remit to develop, scale up, manufacture and clinical supplies across all medicines across small molecule, biopharm, and new modalities. You will drive the modernisation of manufacturing platforms in the pilot plants to enable the acceleration of the ambitious R&D portfolio and drive investment and focus on new capabilities including sterile operations and digitalisation of manufacturing operations as part of CMC Digital Strategy. Reporting to the VP Global Head Clinical Supply Chain and sitting on the CSC leadership team this is a significant and vital role in delivering the R&D portfolio milestones by ensuring all clinical trials are supported seamlessly and on time; and processes are developed and successfully transferred to our Global Supply Chain (GSC) and / or external manufacturing strategic partners. The role will have operations and be based across 6 GSK sites: UK (Stevenage/Ware), USA (UM/UP), Italy (Parma) and Singapore (Jurong) and will comprise the following areas of accountability: - Drug Substance pilot plant operations (small and large molecules) - Drug Product pilot plant operation (oral solid dose) - Drug Product Sterile pilot plant operations - Manufacturing automation - Process safety Key Responsibilities in Detail - Line leadership of global department of ca 300 scientists, engineering, process technicians and manufacturing experts across 6 sites across 4 countries: including 6 GMP Pilot Plants, and a total budget of >£80M. - Responsible for establishing the new integrated global GMP Operations; accountable for the on-time scale up, manufacture and supply to R&D clinical trials, delivering high quality, GMP compliant medicines across all modalities according to R&D objectives and compliance with all internal and external regulations and policies governing clinical supply chain. - Accountable for the implementation of the functional strategy including modernisation and delivery of the optimised operation ready to support the cross-modality R&D Portfolio. - Drives the comprehensive modernization/digitalisation programme as part of deployment of CMC Digital Strategy. - Ensure compliance with all quality and safety regulations/requirements as well as continuous improvement in both. Protecting GSK license to operate through implementation & support of tiered governance structure. - Accountable for providing technical input and clear recommendations to relevant R&D Governance Board(s). - Regularly reviews and implements technologies and ways of working to identify improvements in quality, and efficiency ensuring the clear investment plans for manufacturing technologies across the polit plant network in alignment with partners in GSC; and/or external providers. - Embraces and drives inclusion and diversity to create a modern and dynamic working environment across the function, where people thrive. - Develops and implements a strategic work force plan and a talented and diverse succession pool that is aligned to future needs, reflects a diverse and highly skilled workforce, and incorporates external capability/collaborations. - Measures performance and drive a customer focused, metrics driven, performance management system. - Leads significant change programmes in the department through exceptional planning, robust engagement and communication plans, and excellence in strategy development and deployment. Candidate Profile Basic Qualifications - Masters degree in Science or Engineering - 5+ years of experience in cross modality drug development/manufacturing across all CMC activities - 10+ years of experience and track record of leadership of highly regulated GMP and EHS operations/facilities - Thorough knowledge of FDA/MHRA and equivalent standards as they apply for Pharmaceutical processes, facilities, and validation. - Experience with design and operation of pharmaceutical pilot plants for flexibility and compliance with cGMP's and direct interaction with external regulatory agencies during inspections - 5+ years of experience leading a large global diverse scientific/technical function. Preferred Qualifications - PhD in Science or Engineering - Management of complex and large P&L (internal and external budgets) - Demonstrated ability to influence across functional lines to meet key manufacturing deliverables. - Ability to analyse trend and metrics data (especially related to quality, safety, technical requirements, and performance) to drive continuous improvement. - Track record of delivering complex enterprise change programmes including significant organisation designs as well as major technology deployments. - Ability to effectively communicate and influence key stakeholders at all levels of the organization both internally and externally. - Expansive and visionary thinker to drive strategic vision of the partnerships. - Ability to effectively handle and appropriately escalate issues based on risk in a timely manner. - Experienced in Lean Sigma tools including root cause analysis, FMEA, and data-driven decision making and project prioritization. - Ability to build effective networks across R&D, QA, Global Supply Chain, Regulatory Business Development, Finance – as well as having a strong presence in relevant external networks. Location Ideally, this role is to be based out of the US (Philadelphia). Closing date for applications is Friday December 15th 2023. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. *Why Us?* GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. *Important notice to Employment businesses/ Agencies* GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

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