GMP Quality Operations Lead (Biotech/Pharma)

Collins McNicholas Recruitment & HR Services Group; Sligo; On-site; EUR 90,000 - 120,000; Full time

Job summary

Collins McNicholas Recruitment & HR Services Group is seeking a QA Operations Manager in Sligo, Ireland to lead day-to-day QA oversight of GMP manufacturing. You will ensure products and processes meet regulatory, company and site quality standards while supporting cross-functional operations.

You will develop and mentor the QA team, drive risk-based decision-making, support regulatory audits, and foster a strong shop-floor QA presence across manufacturing and compliance functions.

Qualifications

• 6–8+ years’ experience in biotech/pharma, including 2–3 years managing GMP Quality Operations.
• Advanced degree in Biological/Pharmaceutical Sciences.
• Leadership experience in biologics, vaccines or sterile manufacturing.
• Strong experience with deviations, CAPA, change control and batch review.
• Proven regulatory inspection and audit experience.
• Strong knowledge of EU GMP, EMA, ICH, USP and Ph. Eur.
• Skilled in quality risk management and inspection readiness.
• Proven team leadership and continuous improvement experience.

Responsibilities

• Provide real-time QA support across Manufacturing, QC and Compliance.
• Develop, coach and mentor the QA team.
• Drive strong GMP, problem-solving and risk-based decision-making.
• Build effective cross-functional relationships and resolve quality issues.
• Support regulatory audits and inspections.
• Lead quality risk assessments across manufacturing and site operations.
• Support new products, process changes and facility upgrades.
• Oversee deviations, CAPAs and continuous improvement.
• Maintain a strong shop-floor QA presence and escalated quality risks.

Skills

Leadership

GMP Knowledge

QA Oversight

Problem Solving

Risk Management

Cross-functional Collaboration

Audit Readiness

Continuous Improvement

Education

Advanced degree in Biological/Pharmaceutical Sciences

Job description

Collins McNicholas Recruitment & HR Services Group is seeking a QA Operations Manager in Sligo, Ireland to lead day-to-day QA oversight of GMP manufacturing. You will ensure products and processes meet regulatory, company and site quality standards while supporting cross-functional operations.

You will develop and mentor the QA team, drive risk-based decision-making, support regulatory audits, and foster a strong shop-floor QA presence across manufacturing and compliance functions.