The Role
We are seeking an experienced Director of Quality Assurance / Qualified Person (QP) to provide strategic and operational leadership across QA within a sterile manufacturing facility.
The role will lead Batch Release, Incoming Inspection and Investigations/CAPA, ensuring products are released in compliance with cGMP, regulatory and internal quality requirements, while driving robust investigations, effective CAPAs, inspection readiness and continuous improvement.
A key focus will be people leadership and development, building high-performing teams, strong decision-makers and a culture of accountability, collaboration and quality excellence.
This is a fully site based role.
Key Responsibilities
- Lead the Batch Release, Incoming Inspection and Investigations/CAPA teams, supporting the QP function and ensuring compliant, timely product release.
- Provide Quality oversight of batch release, deviations, investigations, CAPAs, change controls, risk assessments and the QMS.
- Act as a senior Quality approver and ensure effective documentation and data integrity, including batch records, SOPs and quality documentation.
- Lead and support regulatory inspections, customer audits and self-inspection programmes, maintaining a high level of inspection readiness.
- Monitor Quality metrics and KPIs, identifying trends and driving risk-based improvements.
- Partner with Manufacturing, Packaging, QC, R&D, Regulatory Affairs, Supply Chain and Global Quality to ensure effective Quality oversight.
- Lead, coach and develop the QA organisation, strengthening capability, accountability and succession.
About You
- QP certified/eligible, with a Bachelor's degree in Pharmacy, Chemistry, Microbiology or a related scientific discipline; advanced degree preferred.
- Significant pharmaceutical experience within sterile/aseptic manufacturing and a strong understanding of cGMP requirements.
- Strong knowledge of EU/UK and US GMP regulations, including Annex 1, with experience supporting regulatory inspections and audits.
- Proven expertise in contamination control, batch release, investigations, CAPA, change control, risk management and QMS.
- Experienced people leader with a track record of building and developing high-performing Quality teams.
- Strong strategic, analytical and problem-solving skills, with the ability to make sound, risk-based decisions in a fast-paced environment.
- Excellent communication, influencing and stakeholder-management skills.
If this role looks like a good fit click the 'Apply now' button or reach out to Kellie on 021 2300 300 for a confidential discussion
