QA Operations Lead - GMP & Compliance

Collins McNicholas Recruitment; Sligo; On-site; EUR 90,000 - 120,000; Full time

Job summary

Collins McNicholas Recruitment in Ireland is seeking a QA Operations Manager to lead day-to-day QA oversight of GMP manufacturing. You will manage deviations, CAPAs, batch records and drive a strong shop-floor QA presence while supporting cross-functional operations and regulatory inspections.

The role requires 6–8+ years in biotech/pharma with 2–3 years in GMP Quality Operations, plus an advanced degree in Biological/Pharmaceutical Sciences and proven leadership in biologics, vaccines or

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 ESCALATE quality risks.

Skills

QA leadership

GMP knowledge

Regulatory inspections

Risk management

Problem solving

Cross-functional collaboration

Team leadership

Education

Advanced degree in Biological/Pharmaceutical Sciences

Job description

Collins McNicholas Recruitment in Ireland is seeking a QA Operations Manager to lead day-to-day QA oversight of GMP manufacturing. You will manage deviations, CAPAs, batch records and drive a strong shop-floor QA presence while supporting cross-functional operations and regulatory inspections.

The role requires 6–8+ years in biotech/pharma with 2–3 years in GMP Quality Operations, plus an advanced degree in Biological/Pharmaceutical Sciences and proven leadership in biologics, vaccines or