Position Summary
The Head of Manufacturing Compliance is a senior manufacturing‑facing leadership role responsible for strengthening GMP execution, commercial compliance readiness, and continuous quality improvement across manufacturing operations, and risk‑based compliance management.
This role focuses on identifying and closing GMP execution gaps from the manufacturing side, ensuring consistent, risk‑controlled, and inspection‑ready operations from clinical through commercial manufacturing. The position partners closely with Quality Assurance, Engineering, MSAT, and Site Manufacturing teams to translate regulatory expectations into practical, robust, and sustainable manufacturing processes and culture.
Key Responsibilities
1. GMP Execution & Manufacturing Compliance Oversight
- Own and drive manufacturing‑side GMP compliance strategy, with particular emphasis on late‑stage and commercial manufacturing operations.
- Lead systematic GMP execution gap analysis across manufacturing sites, including risks related to microbial contamination, cross‑contamination, people, processes, etc.
- Translate regulatory and quality system requirements into clear, executable manufacturing expectations and operational standards.
- Support consistent GMP execution across shifts, campaigns, and sites, especially during scale‑up and commercial conversion.
2. Commercial Readiness & Inspection Support
- Partner with Manufacturing, QA, and MSAT teams to ensure commercial manufacturing readiness, including PPQ execution, campaign management, and lifecycle activities.
- Proactively identify and mitigate compliance risks impacting commercial supply continuity, including contamination and cross‑contamination risks.
- Support preparation for regulatory inspections, audits, and client audits from a manufacturing execution perspective.
- Coach and support manufacturing teams including SMEs in inspection‑facing contents, behaviors, and narratives.
3. Microbial Contamination & Cross‑Contamination Control
- Provide oversight for microbial contamination prevention and control, including aseptic operations, cleanroom execution, environmental monitoring practices, and contamination investigations.
- Lead manufacturing‑side cross‑contamination risk assessment and control, particularly in multi‑product and multi‑campaign biologics operations.
- Ensure contamination and cross‑contamination risks are effectively assessed, mitigated, and embedded into routine manufacturing execution, facility use, and change management.
- Partner with QA and Engineering to ensure contamination control strategies are defensible, practical, and inspection‑ready.
4. Continuous Quality Improvement (CQI) – Manufacturing Focus
- Drive continuous quality improvement initiatives rooted in manufacturing operations, focusing on right‑first‑time execution, contamination prevention, and error prevention.
- Analyze manufacturing deviations, contamination events, recurrent issues, and near misses to identify systemic execution gaps and improvement opportunities.
- Partner with QA to ensure CAPAs are practical, effective, and sustainable within manufacturing operations.
- Promote a strong quality and compliance culture within manufacturing teams, emphasizing accountability, ownership, and proactive risk management.
5. Cross‑Functional Integration & Governance
- Work closely with Quality Assurance, Manufacturing, Engineering, MSAT, Supply Chain, and EHS to ensure alignment on compliance, contamination control, and execution priorities.
- Contribute to governance forums related to quality performance and commercial readiness.
- Support global or multi‑site alignment of manufacturing compliance and contamination control standards and best practices.
6. Capability Building & Leadership
- Build manufacturing compliance and contamination control capabilities through targeted training, coaching, and leadership engagement.
- Mentor manufacturing leaders and frontline teams on GMP thinking, risk awareness, microbial control, and disciplined execution.
- Develop and scale best practices for manufacturing compliance across sites and regions.
Qualifications & Experience
Education
- Bachelor’s degree or above in Life Sciences, Chemical Engineering, Biochemical Engineering, or a related discipline.
- Advanced degree is preferred.
Experience
- Minimum 10–15 years of experience in GMP biologics manufacturing or QA, with substantial exposure to commercial manufacturing operations.
- Experience with FDA and EMA inspections is preferred, including inspection preparation, on‑site support, and post‑inspection follow‑up from a manufacturing perspective.
- Strong hands‑on experience in manufacturing risk management, including microbial contamination control and cross‑contamination risk management.
- Demonstrated experience identifying and closing GMP execution gaps within manufacturing organizations.
- Experience working cross‑functionally with Quality, Engineering, and Technical teams in complex GMP environments.
Technical & Leadership Competencies
- Deep understanding of cGMP requirements as they apply to manufacturing execution, contamination control, and commercial operations.
- Strong judgment in balancing compliance rigor with operational practicality.
- Ability to influence senior manufacturing and quality leaders without direct line authority.
- Excellent communication skills, with the ability to translate regulatory expectations into actionable operational guidance.
- Strong problem‑solving mindset, with a focus on prevention, sustainability, and continuous improvement.
Reporting & Interfaces
- Reports to: SVP / Head of Manufacturing / Global Manufacturing Leadership (to be defined)
- Key Interfaces: Manufacturing Leadership, QA, MSAT, Engineering, Supply Chain, EHS, Site Heads