About the job

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 Russellcourtney.russell@collinsmcnicholas.ie+353 (0) 71 9108062

Responsibilities

About the job

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 Russellcourtney.russell@collinsmcnicholas.ie+353 (0) 71 9108062