Director QA QP

Morgan McKinley; Galway; On-site; EUR 120,000 - 180,000; Full time

Job summary

Morgan McKinley is seeking an experienced Director of Quality Assurance / Qualified Person (QP) to provide strategic and operational leadership across QA in a sterile manufacturing facility in Ireland. The role leads Batch Release, Incoming Inspection and Investigations/CAPA, ensuring compliant product release and strong data integrity.

You will shape a high-performing QA team, foster accountability, and drive continuous improvement while collaborating with Manufacturing, QC, R&D, Regulatory

Qualifications

• QP certified/eligible.
• Significant pharmaceutical experience within sterile/aseptic manufacturing.
• Strong knowledge of EU/UK and US GMP regulations incl. Annex 1.
• 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 high-performing Quality teams.
• Strong strategic, analytical and problem-solving skills.

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.

Skills

Quality management

FDA Qualified Person

QP

Quality Director

Audit readiness

Regulatory compliance

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology or related

Job description

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.

Skills

• Quality management
• FDA Qualified Person
• QP
• Quality Director
• Audit readiness
• TPBN1_IJ