Pfizer
Japan - Aichi
+ 2 other locations
・This position will be part of Pfizer ES Global Biopharmaceuticals Group (1) and will be responsible for oversight of CMOs that supply products.
・This position is responsible for managing business relations, operations and performance from a portfolio of Contract Manufacturers Organisations (CMOs) and Partners located in Japan; with accountability and full P&L responsibility for significant external spend. This position works closely with other ES Operations Leaders, Supply Chain Planners, ES Quality, GTE and Customers at Business Units and Markets with global responsibility for quality, supply and cost from an assigned base of Contractors and Partners. The ES Operations Leader develops and manages implementation of the strategy and tactical execution to ensure timely supply of Drug Products and to achieve cost targets as well as all other key metrics for External Supply Emerging Markets & China (ES EMC). He/she also strongly contributes to the development and execution of ES EMC Virtual Site strategies.
-The ES Operations Lead is responsible for the relationship, and for the performance of the CMOs and Partners in his/her area of portfolio which are located primarily within Japan . Short-term tactics as well as long-term strategies must ensure that every CMO contributes to achieving ES EMC Integrated Manufacturing Excellence metrics and strategic objectives.
-Lead Virtual Site Operations Teams (VSOTs) and provide matrix leadership to all members of the VSOT including but not limited to ES Quality, PPLs, BSLs, supply chain planners, procurement and GTE project leads. The ES Operations Lead is accountable for the results of the VSOT. The activities and responsibilities of the VSOT include:
Manage global stakeholders including but not limited to Product Portfolio Leaders, Brand Supply leaders and Commercial and PGS leadership
Have P&L responsibility for a complex selected portfolio including direct accountability for contract negotiations and external relationship management at CEO level with the contractor base
Development and execution of manufacturing and supply plans and meet market demand for product and meet or exceed supply performance target; this includes supply of APIs, raw materials and components where appropriate.
Development and execution of tactical plans for continuous improvement of CMO shop floor performance in the areas of product quality, EH&S, compliance, customer service and cost.
Review of the status of deviations which impact or may affect product supply. The ES Operations Lead is responsible to secure correct and timely closing of relevant deviations, and when necessary, lead closure of investigations that have not been properly addressed by the CMO.
Oversee and secure timely execution of new product introduction, product changes (including changes of materials and API), product enhancement, localization and product transfer programs. Lead implementation teams where required.
-Ensure that product supply, quality, compliance and cost issues at CMOs are adequately addressed by making extensive use of Operational Excellence tools and mobilizing the necessary resources for support in all required areas. Lead these cross-functional teams where required.
-Collaborate with EH&S to ensure compliance with environmental, health and safety regulations and Pfizer requirements.
-Ensure effective communication of key product supply issues to stakeholders, communication with CM Site Leads and Vice Presidents, with PGS PPLs, and with ES Leadership.
-Partner with ES Quality to ensure CMOs comply with regulatory requirements, cGMP’s, Pfizer Quality Standards and Standard Operating Procedures.
-Manage the cost reduction program:
-Maintain awareness of potential new sourcing opportunities and identify strategic sourcing partners for the manufacture/packaging/testing of pharmaceutical products who share common vision/values with PGS.
-Ensure compliance with Legal Requirements of the “My Anti-corruption Policy & Procedures (MAPP)” and related other legislation as directed by the relevant Pfizer Corporate Policies. The ES Operations Lead is accountable for appropriate documentation of compliance with all requirements.
-Support and actively participate in ES initiatives to drive the business and to enable delivery of key metrics
-Lead assigned project and initiatives for his/her portfolio of contractors including but notlimited to:
-20 - 25% travel required (primarily across Japan).
KEY PERFORMANCE INDICATORS:
1.Supply performance: meet the targets set under ES Integrated Manufacturing Excellence balanced scorecard.
2.Product cost reduction.
3.Quality: no rejects or recalls due to contract manufacturer errors.
Level of Education: Minimum Bachelor’s degree (Science, Engineering, Pharmacy, Economics, Business); MBA preferred.
Experience: Minimum 9 years experience (with advanced degree) in Pharmaceutical Operations (especially in API, vaccines, sterile injectables and/or solid-oral dose) Global Technology, Engineering and Launch (GTEL),
Supply Chain or Quality Operations. External Supply, Procurement, R&D and or Project Management experience is also highly desirable.
Languages: Must be able to communicate in written and spoken Japanese and English
Other Specifics & know-how: Excellent verbal and written communication skills including a demonstrated ability to lead and participate in teams at all levels of management required. Well-developed interpersonal skills (leadership, integrity, team orientation, flexibility, creativity; experience in projects that require collaborative approaches; strong analytical skills; ability to understand business issues and processes; knowledge and understanding of pharmaceutical manufacturing processes and regulatory requirements.
Bonus Points If You Have (Preferred Requirements)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Manufacturing