Head of Manufacturing Operations
You will lead day‑to‑day manufacturing at a UK pharmaceutical site producing unlicensed, patient‑critical medicines. This role combines strategic oversight with hands‑on leadership, ensuring GMP excellence, operational efficiency, and uncompromising patient safety.
Key Accountabilities
- Manufacturing Governance: Embed GMP, data integrity, and SOP compliance as standard operating practice, maintaining a trained, inspection‑ready workforce.
- Production Delivery: Translate forecasts and patient‑specific demand into robust production plans, controlling material flow, segregation, and availability.
- Batch Execution: Ensure right‑first‑time batch delivery through approved documentation, accurate reconciliation, and rapid issue resolution.
- Facilities & Equipment: Partner with Engineering to maintain qualified, calibrated facilities with effective contamination control.
- Validation & Change: Lead validation activities, technology transfers, and process improvements under formal change control.
- Investigations & Improvement: Drive root cause investigations, implement effective CAPAs, and reduce deviations using Lean / Six Sigma approaches.
- People Leadership: Build and develop a high‑performing manufacturing team with a strong safety‑ and quality‑first culture.
- Audit Readiness: Act as manufacturing SME during inspections, maintaining constant audit readiness.
- GDP & Controlled Drugs: Support GDP and controlled drug compliance where applicable, working with the Responsible Person.
- Quality Partnership: Work in close partnership with Quality leadership to oversee compliance, documentation approval, supplier performance, batch review, and audits.
Experience & Credentials
- Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, Engineering, or related discipline.
- 7+ years’ experience in GMP pharmaceutical manufacturing, including 3–5 years in senior operational leadership.
- Proven delivery of production targets with improvements in yield, right‑first‑time performance, and deviation reduction.
- Strong background in investigations, CAPA, change control, and cross‑functional leadership.
- Experience in small‑batch or patient‑specific manufacturing is desirable.
Leadership Profile
- Decisive, composed, and patient‑focused under pressure.
- Deep technical credibility in GMP manufacturing operations.
- Structured, analytical, and data‑driven in decision making.
- Clear, influential communicator across all levels.
- A visible role model for compliance, integrity, and continuous improvement.
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