GMP Quality Lead (Contract) — Fast-Start Impact

Myn; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

Myn is seeking an experienced Quality leader to own the site Quality function in Galway. You will ensure product quality, regulatory compliance, and audit readiness across manufacturing operations in a fast-paced GMP environment.

This hands-on role requires effective people management, strong knowledge of EU GMP/HPRA, and proven experience supporting regulatory inspections and CAPA/change control. A fixed-term engagement with a cross-functional quality team is expected.

Qualifications

• Degree in a relevant scientific discipline.
• Substantial experience in a Quality role within pharmaceutical or biopharmaceutical manufacturing.
• Hands-on involvement in regulatory inspections (HPRA and/or FDA).
• Experience with deviation, CAPA, change control and electronic QMS platforms.

Responsibilities

• Provide day-to-day leadership of the site Quality Assurance and/or Quality Control function, managing a team of QA/QC Officers/Specialists.
• Ensure ongoing compliance with EU GMP, HPRA requirements, and applicable ICH guidelines across manufacturing operations.
• Own deviation, CAPA, change control, and complaints management systems with root-cause resolution.
• Lead batch record review and product release activities to ensure right-first-time quality.
• Prepare the site for regulatory inspections and customer audits.
• Maintain and improve the site's Quality Management System (QMS) to be audit-ready.
• Drive quality metrics reporting and trend analysis, escalating risks to site leadership.
• Support validation, technology transfer, and new product introduction from a Quality perspective.
• Coach and mentor the Quality team and liaise with cross-functional stakeholders.

Skills

Leadership

Quality Assurance

Regulatory compliance

Audits/inspections

Problem-solving

Cross-functional collaboration

Education

Degree in life sciences

Tools

Electronic QMS

Job description

Myn is seeking an experienced Quality leader to own the site Quality function in Galway. You will ensure product quality, regulatory compliance, and audit readiness across manufacturing operations in a fast-paced GMP environment.

This hands-on role requires effective people management, strong knowledge of EU GMP/HPRA, and proven experience supporting regulatory inspections and CAPA/change control. A fixed-term engagement with a cross-functional quality team is expected.