Quality Lead

Quality Lead Pharmaceutical Development

Dublin onsite

An exciting senior Quality opportunity supporting pharmaceutical products across development, NPI, scale-up and commercialisation. You'll work across Quality, Analytical, Manufacturing and CMC, with exposure to OSD, API, external CMOs and pharmaceutical manufacturing.

Key Responsibilities

• Provide QA oversight of analytical qualification, method validation, stability and data integrity.
• Own the Cleaning Validation and Cleaning Verification programme.
• Provide hands-on QA support for GMP manufacturing and on-floor activities across product development and manufacturing programmes.
• Support batch disposition, batch record review and QP disposition.
• Review deviations, CAPAs, change controls, SOPs and risk assessments.
• Partner with Analytical Development, Manufacturing and Regulatory/CMC teams.
• Support GMP audits, inspections and regulatory activities.

Experience Required

• BSc in a scientific discipline or equivalent.
• 10+ years' pharmaceutical industry experience.
• Strong QA, analytical, manufacturing and cleaning validation experience.
• OSD experience highly desirable.
• Strong knowledge of FDA/EU cGMP, data integrity and validation lifecycle principles.
• Experience with Veeva, TrackWise Digital, ValGenesis and/or SAP advantageous.
• Strong stakeholder management and problem-solving skills.