The Position:

The Director Contract Manufacturing Operations will be responsible for overseeing the full lifecycle of outsourced manufacturing for IVD/FDA regulated clinical products. This includes selecting Contract Manufacturing Organizations, managing the transfer of manufacturing processes, and ensuring ongoing operational performance through established KPIs. The role requires close collaboration with internal stakeholders such as Product Development, Market Access, Quality, Regulatory, and Supply Chain to ensure compliance, quality, and timely delivery of products.

Key Responsibilities:

• Lead the evaluation and selection process for CMOs, including due diligence, capability assessments, negotiations, and contracting.
• Develop and manage CMO relationships to ensure alignment with manufacturing strategies and IVD/FDA requirements.
• Plan and manage the tech transfer of manufacturing processes to CMOs, ensuring seamless execution and compliance with quality and regulatory standards.
• Collaborate with development teams to develop transfer protocols, process validations, and QC/troubleshooting strategies.
• Establish clear communication channels and governance for monitoring transfer progress.
• Define, implement, and monitor KPIs for CMO performance, including production output, quality metrics, cost management, and compliance standards.
• Develop corrective and preventive action plans for any performance deviations, ensuring adherence to timelines and quality standards.
• Lead regular business reviews with CMOs, assessing performance and driving continuous improvement initiatives.
• Work closely with internal teams including Development, Quality, Regulatory, Technical, and Supply Chain to align CMO activities with broader operational and strategic objectives.
• Ensure that all CMO operations meet regulatory compliance, particularly IVDR requirements including participation in quality/regulatory audits.
• Facilitate cross-functional meetings to review CMO performance, discuss potential risks, and develop mitigation plans.
• Drive operational efficiency in CMO management, focusing on cost, quality, and delivery improvements.
• Proactively identify and address risks associated with CMO operations, ensuring robust contingency plans are in place.
• Implement best practices in CMO management, including supplier development, risk assessment, and lifecycle management.
• Provide strategic guidance to senior leadership on CMO-related matters, contributing to long-term planning and operational strategies.

Qualifications:

• Bachelor’s degree in a scientific, engineering, or related field; advanced degree preferred.
• 10+ years of experience in manufacturing operations, with at least 5 years in a CMO management role, ideally in the medical device or diagnostic sectors.
• Strong understanding of IVD/FDA requirements and experience managing IVDR and FDA-compliant manufacturing processes.
• Proven experience in tech transfer, manufacturing process optimization, and KPI management.
• Excellent leadership skills with the ability to influence and collaborate across functions.
• Strong analytical, problem-solving, and decision-making skills.
• Ability to travel as needed to CMO sites.

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