External Supply Technical Manager is a key function to External Supply Pharma which is part of GMS and is responsible for the management of Rx Contract Manufacturing Organisations (CMOs) globally (approximately 100 CMOs globally).
The Technical Manager is responsible and accountable for the provision of technical support to all manufacturing and packaging related processes (covering multiple dose forms) within External Supply Pharma. To achieve this objective, the Technical Manager works with a multi-functional team of Procurement, Regulatory (incl. GPAR), Technical, Finance, Supply, Global Project SS and Quality professionals across the Global network.
The Technical Manager is responsible and accountable for the provision of technical support to all manufacturing and packaging related processes (covering all dose forms) within External Supply Pharma, including:
• Supporting ongoing product supply from ES Pharma by ensuring robust and capable processes are in place and monitored.
• Technical-/trouble shooting-support to ES supply teams for ongoing manufacture packaging and supply of product from third party contractors.
• Technical process support for the introduction of New Products into new or existing CMOs to ensure that they meet GSK requirements, are capable and robust, through close liaison and collaboration with R&D.
• Support of product transfers from GSK sites to a CMO, between CMOs or from CMOs to GSK sites, resulting from product / dose form source plans and strategic reviews.
• Owner of repository of knowledge and knowledge transfer associated with new and transferred products.
• Impact assessment and support of the process changes (GSK or CMO driven) related to active materials, excipients, primary and secondary packaging materials incl. risk assessment.
• Ensure with Quality Assurance, (ESQA) that necessary validation activities have been planned and executed to current standards (e.g. Product Lifecycle Management) in line with GSK QMS by CMOs.
• Ensure that technical compliance gaps in manufacturing and packaging at CMOs are highlighted and plans are developed to close the gaps.
• Technical project support related to all manufacturing/packaging related projects at CMOs
• Applying OE tools and principles in the implementation of technical projects and improvement initiatives.
Under the direction of a Technical Director – External Supply Pharma, the Technical Manager, exercises the key technical and professional skills to effectively manage the technical interface with new and existing external Contract Manufacturers.
• 10 years of experience in Production/Technical Operational support covering multiple Dose-Forms and Technologies
• Documented pharma experience in New Product Introduction, Product Transfers and Change Control and Issue Resolution (Troubleshoot, RCA, TRA)
• Practical knowledge about supplier qualifications, quality systems (QMS), validation, due diligence and managing Customer complaint with Adverse Event Reporting
• Solid understanding of regulatory dossier update and product releases.
• Experience in leading cross-functional, global teams within GSK and the supply base.
• University degree in Pharmacy, Chemistry or Engineering
• Ability to play as strong interface for external contractors and GSK stakeholders, establishing relationships, acting with business maturity and within applied guidelines
• Ability to ensure the robust and capable processes
• Ability to rapid finding issues on performance and technical process from Contract Manufacturers and implement right resolutions
• Supportive approach to development of project plans for major technical and change projects
• Expressing Operational Excellence in everyday duties
• Fluent command of Business English
• Willingness to travel (min. 40% working time)
• >10 years of experience in Production/Technical Operational support covering multiple Dose-Forms and Technologies
• Practical knowledge of external supply business and supply chain inside GSK
• Career at one of the leading health-care companies
• Opportunity to work with a wide range of dose forms, products and cultures (countries and companies) and develop self as a result
• Opportunity to act as key interface between GSK, markets and external manufacturing contractors
• Opportunity to work strategically as well as at an operational level
• Company culture based on our values: patient focus, integrity, respect and transparency
• Atmosphere of trust which let you grow professionally.