Contract Manufacturing Director leading operational activities for outsourced pharmaceutical systems. Ensuring regulatory compliance and performance excellence for CMOs in the pharmaceutical industry.
Responsibilities
Responsible for the strategic and operational leadership of all outsourced pharmaceutical systems manufacturing activities
Act as the primary interface between the company and CMOs
Drive performance excellence and ensure regulatory compliance
Lead the relationship with assigned CMOs, ensuring strong operational performance and continuous improvement
Establish and oversee governance structures and monitor key metrics
Develop and execute the external manufacturing strategy for assigned product portfolio
Support business case development for transferring products to new CMOs or scaling capacity
Drive productivity programs and cost-reduction initiatives across the external network
Ensure robust demand planning, capacity planning, and inventory strategies with CMOs
Ensure CMOs operate in full compliance with cGMP, ICH, FDA, EMA, and global regulatory standards
Lead or support technology transfer activities to and from CMOs
Partner with Supply Chain, Quality, Regulatory, Procurement, R&D, Finance, and Technical Operations to ensure end-to-end 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.
Benefits
Comprehensive package of compensation and benefits
Investment in associates’ well-being and development
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