Our client, a multinational pharmaceutical organisation is looking to engage with a External Supply Operations Consultant.
This position is responsible for managing the business relationship, operations, and performance of a portfolio of Contract Manufacturing Organisations (CMOs) that launch, manufacture and supply finished pharmaceuticals 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 Supply Chain, Quality, Technical Services, Procurement 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.
- The ES Operations Lead is responsible for the business relationship and for the performance of a portfolio of pharmaceutical product Contract Manufacturing Organisations (CMOs) and supply partners across a range of technologies that may include oral dose, sterile injectables etc.
- Leadership on short-term tactics as well as on long-term strategies ensures that every CMO contributes to achieving the ES targets and strategic objectives.
- She or he provides operational leadership through a matrix organization to all members of the VSOT including quality, supply chain planners, procurement, 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:
o 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
o Co-ordination of required activities across PGS to bring-to-market new Products which require sourcing from a 3 rd Party, and which were acquired through business development and Alliance deals
o Development and execution of manufacturing and supply plans and meet market demand for product and meet or exceed supply performance targets
o Collaborate with stakeholders globally including but not limited to Product Portfolio Leaders, Brand Supply leaders, Commercial, Business Development and PGS leadership
o Act as a “Change Control Committee” for relevant changes.
o 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.
o Review of the status of deviations which impact or may affect product supply. The ES Operations Manager 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, launch, process changes (including changes of materials and API), product enhancement, and product transfer programs. Lead implementation of localization teams where required.
- Ensure that product supply, quality, compliance and cost issues are adequately addressed by making extensive use of Operational Excellence tools and by 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 reports in alignment with Pfizer’s Integrated Manufacturing Excellence approach (IMEx).
- Partner with ES Quality to ensure CMOs comply with regulatory requirements, cGMP’s, Pfizer Quality Standards (PQS) and Standard Operating Procedures.
- Manage the cost reduction program:
o Identify cost reduction opportunities with CMOs and supply partners
o Validate the financial impact and ensure the opportunities are captured and reported in the Long-
Range Plan and the Operational Plan
o Oversee execution and implementation, lead the execution team as appropriate
o 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” 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.
- 20 - 25% travel required
TECHNICAL SKILL REQUIREMENTS:
Level of Education: Minimum Bachelor degree (e.g. Engineering, Science, Pharmacy or Management) or equivalent
experience; MBA preferred
Experience – At minimum, greater than 10 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 injectable, specialty or in other technologies.
Project Management experience is also highly desirable.