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Contract Manufacturing Director

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BD

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Location:
United Kingdom , Swindon

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

101700.00 - 155100.00 GBP / Year
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Job Description:

As Contract Manufacturing Director you will be responsible for the strategic and operational leadership of all outsourced pharmaceutical systems manufacturing activities. The role ensures that Contract Manufacturing Organizations (CMOs) deliver products safely, compliantly, on time, and at the right cost and quality. you will act as the primary interface between the company and CMOs, driving performance excellence, ensuring regulatory compliance, and optimizing the external supply network.

Job Responsibility:

  • CMO Governance & Performance Management: Lead the relationship with assigned CMOs, ensuring strong operational performance and continuous improvement
  • Establish and oversee governance structures
  • Monitor key metrics
  • Lead issue escalation, resolution pathways, and structured problem-solving with CMO partners
  • External Manufacturing Strategy: Develop and execute the external manufacturing strategy for assigned product portfolio
  • Assess capabilities, risks, and opportunities across the CMO landscape
  • Contribute to make/buy decisions, outsourcing strategies, and network optimization initiatives
  • Support business case development for transferring products to new CMOs or scaling capacity
  • Operational Excellence & Cost Management: Drive productivity programs and cost‑reduction initiatives across the external network
  • Ensure robust demand planning, capacity planning, and inventory strategies with CMOs
  • Review and challenge CMO proposals for cost adjustments, change controls, and capital needs
  • Negotiate commercial and operational terms in partnership with Procurement
  • Quality & Compliance: Ensure CMOs operate in full compliance with cGMP, ICH, FDA, EMA, and global regulatory standards
  • Partner with Quality Assurance on audits, inspection readiness, and remediation plans
  • Oversee change controls, deviation investigations, CAPAs, and risk assessments related to outsourced manufacturing
  • Support regulatory submissions (CMC sections, responses to HA queries, product variations)
  • Technology Transfer & Lifecycle Management: Lead or support technology transfer activities to and from CMOs
  • Coordinate technical teams for process validation, scale-up, and launch readiness
  • Drive lifecycle management activities, including formulation changes, process improvements, and cost optimization projects
  • Ensure robust knowledge transfer and documentation standards during transfers
  • Cross‑Functional Leadership: Partner with Supply Chain, Quality, Regulatory, Procurement, R&D, Finance, and Technical Operations to ensure end‑to‑end performance
  • Provide leadership to multidisciplinary project teams involving internal and external stakeholders
  • Act as the internal subject‑matter expert for external manufacturing strategy and performance

Requirements:

  • A minimum of 10 years of experience in the pharmaceutical, medical devices, automotive or consumer goods industry
  • At least 5 years of direct experience in external/contract manufacturing
  • Proven leadership in managing CMOs across multiple geographies and technologies, including (but not limited to) sterile manufacturing, oral solid dose, biologics, active pharmaceutical ingredients (API), and packaging
  • Strategic Vision: Ability to shape external manufacturing networks and anticipate risks
  • Technical Depth: Solid grasp of manufacturing technologies, quality, and regulatory standards
  • Influence & Negotiation: Skilled in leading without authority and managing external partners
  • Analytical Thinking: Strong problem-solving and data-driven decision-making
  • Operational Rigor: Proven track record in planning, execution, and performance management
  • Collaborative Leadership: Effective in matrixed, cross-functional environments
  • Business Insight: Understanding of cost drivers, contracts, and financial levers

Additional Information:

Job Posted:
March 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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