POSITION SUMMARY:
This position is responsible for managing the business relationship, operations and performance of Dalian CMO that launch, manufacture and supply finished pharmaceuticals for Pfizer in China in different dosage forms. Through a matrix organization, this position will provide operations leadership to a Virtual Site Operations Team (VSOT) which includes representatives from PGS Supply Chain, Quality, Technical Services, Procurement, EHS and Finance and which – together - has responsibility for launch preparations and for routine quality, supply and cost of finished pharmaceutical products from DL CMO. She or he works closely with our Customers in Commercial Business Units, in Alliance and BD to bring to market and to manage supply of our products for Patients. The External Supply Operations Lead develops and manages implementation of strategy and tactical execution to secure timely launch and product supply and to achieve cost improvement targets and other outcome metrics. She or he also contributes strongly to the development and execution of PGS Emerging Markets &China and External Supply strategies.
POSITION RESPONSIBILITIES:
- The ES Operations Lead is responsible for the business relationship and for the performance of Dalian CMO across a range of technologies that may include solid oral dose and sterile injectables etc. Leadership on short-term tactics as well as on long-term strategies ensures that CMO contributes to achieving the ES targets and strategic objectives.
- She or he provides leadership through a matrix organization to all members of the VSOT including but not limited to quality, supply chain planners, procurement, EHS, finance and technical project colleagues. The ES Operations Lead is accountable for the results of the VSOT. The activities and responsibilities of the VSOT include:
- Own P&L responsibility for selected portfolio including direct accountability for contract negotiations and external relationship management with the contractor base up to CEO level
- Collaborate with local China team, global team and VSOT members to set up and maintain the relative systems to meet China MAH requirement.
- Development and execution of manufacturing and supply plans and meet market demand for product and meet or exceed supply performance targets
- Collaborate with stakeholders globally including but not limited to Product Portfolio Leaders, Brand Supply leaders, Commercial, Business Development and PGS leadership
- Act as a “Change Control Committee” for relevant changes.
- Develop and execute tactical plans for continuous improvement of CMO performance in the areas of product quality, environmental health and safety, compliance, customer service and product 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.
- With the request from line manager, to co-ordination of required activities across PGS to bring-to-market supply new Products which require sourcing from a 3rd Party, and which were acquired through business development and Alliance deals
- Lead /support 2nd wave MAT & PLENC project
- Support Dalian site separation project as necessary
- Oversee and secure timely execution of new product introduction, launch, process changes (including changes of materials and API), product enhancement, and product transfer programs.
- Ensure that product supply, quality, compliance and cost issues 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 CMO compliance with environmental, health and safety regulations and alignment with Pfizer’s Climate and Sustainability strategy.
- Secure effective communication of key product supply issues to stakeholders – this includes accurate and timely updating the weekly supply and hot topic reports in alignment with the IMEX approach.
- Partner with ES Quality to ensure CMO comply with regulatory requirements, cGMP’s, Pfizer Quality Standards and Standard Operating Procedures.
- Manage the cost reduction program:
- Identify cost reduction opportunities with CMO and supply partners
- Validate the financial impact and ensure the opportunities are captured and reported in the Long-Range Plan and the Operational Plan
- Oversee execution and implementation, lead the team for execution as appropriate
- Meet or exceed annual budget cost reduction target
- Maintain awareness and intelligence of potential new sourcing and business development opportunities and identify strategic sourcing partners who share common vision/values for the manufacture/packaging/testing of pharmaceutical products
- Secure compliance with Legal Requirements of the “Foreign Corruption Policy Act” (FCPA”) 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 such requirements.
- Lead assigned project and initiatives for his/her portfolio of contractors including but not limited to:
- Serialization
- Business Continuity Plans and management of risk
- Supplier Network Collaboration
- Environmental Sustainability
- Must be based in Dalian. ~15 travel required
KEY PERFORMANCE INDICATORS:
Launch and Supply performance: sustained ability to meet launch targets and other key ES Operations Outcome Metrics Compliance: Achievement of Quality and EH&S metrics Demonstrated continuous improvement of performance Product cost reduction. MAT & PLENC project on time
TECHNICAL SKILL REQUIREMENTS:
Level of Education: Minimum Bachelor degree of medical or Pharmacy education background; MBA preferred
Experience – At minimum, greater than 15 years of experience in one or more Pharmaceutical supply functions; e.g. in Operations, Technical Services, Supply Chain, Quality Operations, External Supply and/or Procurement.
Proven experience in manufacture and supply of pharmaceuticals in different forms – solid oral dose, sterile injectables, vaccines.
Project Management experience is also highly desirable.
Languages: Fluency in Mandarin and in 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 is 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.
ORGANIZATIONAL RELATIONSHIPS:
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Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Manufacturing
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