Quality Lead | Product & Manufacturing
Midlands | onsite
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.
The Next Step for You
Should this position be of interest to you, please forward your CV
