Overview of your 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.
- 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.
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062