1+ months

External Supply Operations Lead ( Production Responsible)

Hedgesville, WV 25427

This position participates in managing the business relationship, operations and performance of a portfolio of Contract Manufacturing Organisations (CMOs) and Partners that launch, manufacture and supply finished pharmaceuticals in different dosage forms for Pfizer in China.. Through a matrix organization, this position will participate in a Virtual Site Operations Team (VSOT) which includes representatives from 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 an assigned portfolio of Partners in China.

She or he works closely with CMO partners, developing the manufacturing plans and oversight the execution of manufacturing activities at CMO sites, to secure timely launch and manage supply of our products for Patients in accordance with China regulatory requirements, and also to achieve cost improvement targets and other outcome metrics.


Production responsible:

+ To ensure products manufactured and stored according to approved operating procedures in order to obtain the quality required.

+ To ensure strict implementation of the various procedures related to production operation.

+ To ensure that the batch production records, and batch packaging records are checked and signed by an authorized person and submitted to the quality management department.

+ To ensure all the prerequisites are met before manufacturing any of batches.

+ To ensure the maintenance of premises and equipment to keep them in good working conditions.

+ To ensure that the various necessary validations are done.

+ To ensure that the required before-work training and continuing training of personnel related to production are carried out, and training content is adjusted according to real needs.

This position participates in managing business relationship and performance of a portfolio of pharmaceutical product Contract Manufacturing Organisations (CMO) and supply partners in China across a range of technologies that may include monoclonal antibodies, solid oral dose, sterile injectables, vaccines, etc.

She or he participates on a VSOT and contributes to the goal achievement of the VSOT, includes:

+ Share Profit & Loss responsibility for selected portfolio

+ Development and execution of manufacturing and supply plans and meet market demand for product and meet or exceed supply performance targets

+ Act as a "Change Control Committee" for relevant changes.

+ Work with CMOs to use Operational Excellence tools to perform continuous improvement, improve CMO performance in the areas of product quality, environmental health and safety, compliance, customer service and product cost.

+ Provide technical and operation guidance for deviations / change controls evaluation when necessary

+ Support VSOT to set up and maintain the relative systems to meet China Marketing Authorisation Holder requirements.

Oversee and secure timely execution of new product introduction, launch, process changes (including changes of process, materials and API), product enhancement, and product transfer programs for Pfizer Products at CMOs;

Support VSOT to 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.

Collaborate with EH&S to ensure CM compliance with environmental, health and safety regulations and alignment with Pfizer's Climate and Sustainability strategy.

Support to 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 CMOs compliance with regulatory requirements, cGMP's, Pfizer Quality Standards and Standard Operating Procedures.

Support cost reduction program:

+ Work closely with CMOs to support the identification of cost reduction opportunities

+ Work with VSOT to ensure the opportunities are captured and reported in the Long-Range Plan and the Operational Plan

+ Oversee execution and implementation as appropriate

+ Support the annual budget cost reduction target

Secure compliance with Legal Requirements of the "Foreign Corruption Policy Act" (FCPA") and related other legislation as directed by the relevant Pfizer Corporate Policies.

Support or 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

20 - 25% travel required


Launch and Supply performance: sustained ability to meet launch targets and other key ES Outcome Metrics Compliance: Achievement of Quality and EH&S metrics Demonstrated continuous improvement of performance Product cost reduction.


**Level of Education** : Minimum bachelor degree (e.g. Engineering, Science, Pharmacy or Management) or equivalent experience;

**Experience -** At minimum, greater than 5-8 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., of which minimal one year practical experience in management of drug production, and have received professional training in relevant products manufactured.

Proven experience in manufacture and supply of pharmaceuticals in different forms - biologics, 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.


Ideal location is Shanghai; other locations in China may also be considered, especially Jiangsu and Zhejiang

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control



Posted: 2021-08-18 Expires: 2021-11-19

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External Supply Operations Lead ( Production Responsible)

Hedgesville, WV 25427

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