Quality Assurance Manager – QA Systems & Compliance (12‑month contract)

About the role

The Technical Operations group of a leading pharmaceutical company in Cork is seeking a QA Systems & Compliance Technical Manager on a 12‑month contract. You will oversee quality systems, ensure GMP and regulatory compliance, and support the delivery of safe, high‑quality medicines.

Key responsibilities

• Act as business process manager for applicable quality systems.
• Assess GMP and regulatory compliance risk areas and implement mitigation measures.
• Collaborate with stakeholders to identify and implement system improvements.
• Analyse performance through metrics, trending and benchmarking.
• Troubleshoot issues and support the business with queries.
• Liaise with global colleagues to share learnings and ensure consistency.
• Provide QA review/approval for Supplier Management, deviations, changes, specifications and technical/quality agreements.
• Support audit and inspection activities, including preparation, participation and follow‑up actions.
• Lead site quality management review processes.

Required profile

• Bachelor’s degree in Pharmaceutical Sciences, Process Engineering or a related discipline.
• 10–15+ years experience in GMP‑regulated pharmaceutical or biotechnology environments.
• 3–5 years in leadership roles with people‑management experience.
• Hands‑on experience supporting regulatory inspections.
• Knowledge of EU GDP guidelines and regional regulatory requirements.
• Proven ability to lead change initiatives and drive compliance improvements.

Required skills

• GMP compliance
• EU GDP guidelines
• Regulatory inspection support
• Quality systems management
• Supplier management processes