A high-impact Quality Lead role offering broad exposure across product development, NPI, OSD/capsule manufacturing, API and external CMOs. You’ll support programmes through development, scale-up and commercialisation while providing hands-on Quality leadership across GMP manufacturing and analytical activities.

Key Responsibilities

• Lead Quality oversight across analytical, manufacturing and validation activities.
• Support GMP manufacturing, NPI and product development activities.
• Oversee cleaning validation/verification and cross-contamination controls.
• Provide on-floor QA support and review GMP manufacturing documentation.
• Support batch disposition and documentation required for QP disposition.
• Manage deviations, CAPAs, change controls and investigations.
• Collaborate with Manufacturing, Analytical, CMC and technical stakeholders.
• Support audits, inspections and regulatory filings.

Experience Required

• BSc in a scientific discipline or equivalent.
• 10+ years’ pharmaceutical industry experience.
• Strong Quality Assurance and GMP manufacturing background.
• OSD and pharmaceutical development experience preferred.
• Strong analytical testing and cleaning validation knowledge.
• Knowledge of FDA/EU cGMP, validation lifecycle and data integrity.
• Experience supporting NPI, scale-up, tech transfer and commercialisation advantageous.
• Strong communication, influencing and problem-solving skills.