QA Operations Manager

Excellent opportunity for a QA Operations Manager with a Leading Life Sciences company in Sligo. The QA Operations Manager leads day-to-day QA oversight of GMP manufacturing, ensuring products and processes meet regulatory, company and site quality standards. The role supports cross-functional operations, drives strong shop-floor QA presence, oversees GMP documentation, deviations and batch records, and proactively manages quality risks.

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.

Knowledge, Skills and Experience Required for the Role:

• 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.

For a confidential discussion and more information on the role contact Courtney Russell

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