Manager, External Manufacturing and Supply

Job purpose

As a Manager, External Manufacturing and Supply Operations, you are responsible for the end-to-end technical and operational oversight of external manufacturing and supply activities across a network of Contract Manufacturing Organizations (CMOs). This role sits at the core of Manufacturing and External Supply Operations and requires a strong technical foundation, the ability to manage multiple concurrent priorities, and to operate effectively in a fast-paced, ambiguous environment.

This position places particular emphasis on batch record review and approval, process oversight, and technical decision-making, ensuring that manufacturing activities are executed in full compliance with cGMP standards and aligned with global supply requirements.

You will collaborate cross-functionally with Quality Assurance, Technical Operations, Regulatory Affairs, and Supply Chain to ensure robust, compliant, and reliable supply for both clinical and commercial products. You will report to the Director, External Supply Operations.

Responsibilities

• Build and maintain strong, technically credible relationships with external CMOs and internal cross-functional stakeholders
• Provide hands-on technical oversight of manufacturing operations at CMOs, ensuring adherence to validated processes, regulatory expectations, and internal standards
• Own and lead the review and approval of batch records, ensuring accuracy, completeness, and compliance with cGMP and product specifications
• Act as the technical authority for batch disposition readiness and support, identifying and resolving issues that may impact product quality or release timelines
• Ensure prompt execution of manufacturing and supply plans, proactively identifying risks and implementing mitigation strategies
• Drive investigation and resolution of deviations, OOS/OOT events, and product complaints, including leading or supporting root cause analysis (RCA) and CAPA development
• Provide technical input and oversight for change controls, ensuring appropriate impact assessments and alignment with regulatory filings and process validation state
• Develop and support deep understanding of manufacturing processes (API, Drug Product, and Packaging) to enable effective troubleshooting and continuous improvement
• Review and approve technical documentation, including but not limited to:
  
  
  • Batch manufacturing and packaging records
  • Specifications and master data
  • Validation protocols and reports (IQ/OQ/PQ)
  • Stability protocols and reports
  • Change controls and deviations
    
    
• Support process validation and ongoing process verification, ensuring continued state of control at CMOs
• Play a key role in technology transfers, process scale-up, and site onboarding, ensuring technical robustness and successful execution
• Partner with Quality and CMO teams to monitor batch execution in real time, ensuring proactive issue identification and resolution
• Ensure effective management of BOMs, master data, and ERP/MRP systems to support accurate production planning and execution
• Lead or participate in routine governance and operational meetings with CMOs, driving accountability and performance improvements
• Support regulatory submissions and CMC activities, ensuring technical accuracy and consistency with manufacturing processes
• Maintain oversight of inventory, production schedules, and supply continuity, ensuring alignment with demand and minimizing supply risk
• Drive a continuous improvement culture, identifying opportunities to enhance process robustness, reduce deviations, and improve right-first-time performance

Qualifications

Education & Core Experience

• BS/BA Degree in Life Sciences, Engineering, or related discipline desirable
• 10+ years' experience across pharmaceutical manufacturing, technical operations, or external supply in a regulated environment
• Strong cGMP manufacturing experience within a pharmaceutical plant environment, with direct exposure to shop-floor operations and batch execution
• Demonstrated expertise in batch record review and approval, with a deep understanding of critical process parameters, in-process controls, and data integrity
• Proven experience working with external CMOs, providing technical oversight and driving performance in outsourced manufacturing environments
• Strong technical knowledge across Drug Product, API, and Packaging operations, with the ability to troubleshoot complex manufacturing issues
• Hands-on experience in deviation management, investigations (OOS/OOT), and CAPA implementation
• Solid understanding of process validation, lifecycle management, and continued process verification
• Experience supporting or leading technology transfers and process scale-up activities
• Strong working knowledge of global regulatory requirements (FDA, EMA, ICH, EU GMP)
• Experience with ERP/MRP systems and manufacturing data structures (BOMs, master data)
• Proven ability to apply risk management principles and make sound technical decisions under pressure
• Excellent communication skills, with the ability to clearly articulate complex technical issues to diverse stakeholders
• Ability to operate effectively in a fast-paced, high-growth environment, managing multiple priorities simultaneously
• Willingness to travel (~25%) to support CMO oversight and on-site technical activities
  
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