QA Director - Quality & Compliance Leader

CareerWise Recruitment; Galway; On-site; EUR 180,000 - 240,000; Full time

Job summary

CareerWise Recruitment in Galway is seeking a Director of Quality Assurance (QP) to lead quality operations in a sterile manufacturing facility. You will oversee Batch Release and CAPA teams, ensuring products meet cGMP and regulatory requirements while driving continuous improvement.

The role demands strategic leadership, hands-on QA expertise, and strong collaboration with Regulatory Affairs, Manufacturing, R&D and Supply Chain.

Qualifications

• QP certified with BSc in Pharmacy/Chemistry/Microbiology or related field; MS/PhD preferred.
• Extensive experience in sterile drug manufacture and cGMP.
• Strong leadership, strategic and regulatory audit experience.

Responsibilities

• Lead Batch Release and CAPA teams and QA operations.
• Ensure regulatory compliance and audit readiness.
• Oversee the Quality Management System (QMS) and document control.
• Collaborate with Manufacturing, Regulatory Affairs, R&D and Supply Chain.
• Mentor and develop the QA team; report KPIs.

Skills

Leadership

QA management

Regulatory knowledge

Aseptic manufacturing

Data analysis

Education

BSc in Pharmacy/Chemistry/Microbiology or related

MS/PhD in a related field

Tools

QMS software

Audit management

Job description

CareerWise Recruitment in Galway is seeking a Director of Quality Assurance (QP) to lead quality operations in a sterile manufacturing facility. You will oversee Batch Release and CAPA teams, ensuring products meet cGMP and regulatory requirements while driving continuous improvement.

The role demands strategic leadership, hands-on QA expertise, and strong collaboration with Regulatory Affairs, Manufacturing, R&D and Supply Chain.