Director of QA – Batch Release & CAPA Leader

Careerwise Recruitment; Galway; On-site; EUR 120,000 - 150,000; Full time

Job summary

CareerWise Recruitment is seeking a Director of Quality Assurance (QP) for a Galway-based client. You will lead two critical QA functions: Batch Release and CAPA, ensuring all drug products meet regulatory and internal standards while driving investigations and continuous improvement.

You will mentor teams, uphold QA excellence, and serve as Senior Director designee when required. The role requires QP certification, strong regulatory knowledge (FDA, EMA), aseptic manufacturing expertise, and a

Qualifications

• QP certification required.
• Experience with regulatory audits (FDA/EMA) and GMP.
• Aseptic manufacturing and cGMP knowledge.

Responsibilities

• Provide strategic and operational leadership to Batch Release and CAPA teams.
• Direct quality oversight of product release, change control, CAPA, deviation management, and risk assessments.
• Oversee QMS maintenance and act as Senior Quality Approver.
• Lead inspections and audits; ensure audit readiness.
• Drive continuous improvement in QA systems and processes.
• Mentor and develop QA teams and foster accountability and collaboration.

Skills

Leadership

Regulatory knowledge

Communication

Education

BSc in Pharmacy / Chemistry / Microbiology

Advanced degree (M.S./Ph.D./MBA) preferred

Job description

CareerWise Recruitment is seeking a Director of Quality Assurance (QP) for a Galway-based client. You will lead two critical QA functions: Batch Release and CAPA, ensuring all drug products meet regulatory and internal standards while driving investigations and continuous improvement.

You will mentor teams, uphold QA excellence, and serve as Senior Director designee when required. The role requires QP certification, strong regulatory knowledge (FDA, EMA), aseptic manufacturing expertise, and a