Quality Assurance Operations Manager

Collins McNicholas Recruitment & HR Services Group; Sligo; On-site; EUR 85,000 - 110,000; Full time

Job summary

Collins McNicholas Recruitment & HR Services Group is seeking a QA Operations Manager for a leading biologics company in Sligo. The role ensures sterile products are manufactured, filled and released in compliance with regulatory standards across NPI to commercial production.

A science degree with pharma experience is required, with MSc and QP eligibility advantageous. You will lead site QPs and regulatory affairs, maintaining current technical knowledge and ensuring adherence to EU and FDA GMP

Qualifications

• Science degree in pharma/healthcare.
• MSc in Industrial Pharmaceutical Science or equivalent; QP eligibility under Article 49/EC.
• Experience in FDA- and EMA-regulated environments.
• Supervisory/management experience in pharma/biotech/manufacturing.
• Experience in drug product manufacturing including aseptic filling and sterilisation.
• Strong audit management and regulatory engagement experience.

Responsibilities

• Ensure NPI and commercial products meet GMP requirements.
• Own and oversee NPI product transfers into commercial manufacturing.
• Manage Site QPs and MQA, including batch release and regulatory support.
• Ensure sterile and aseptic products meet company, customer and regulatory requirements.
• Verify batch manufacture complies with approved marketing authorisations.
• Ensure manufacturing and testing comply with GMP, including EU GMP Annex 1 and FDA requirements.
• Ensure manufacturing and testing processes are validated.
• Ensure deviations and changes are reviewed, approved and managed per procedures.
• Ensure regulatory authorities approve changes requiring manufacturing authorisation updates.
• Maintain current knowledge of relevant technical, scientific and quality requirements.

Education

Science degree in pharma/healthcare

MSc Industrial Pharmaceutical Science

Job description

Excellent opportunity for a QA Operations Manager with a Leading Biologics company in Sligo. Reporting to the QA Director, the QA Operations Manager ensures sterile products, from New Product Introduction (NPI) through to commercial production, are manufactured, filled and released in compliance with regulatory requirements, ensuring patient safety, product efficacy and market-specific regulatory standards.

Overview of your responsibilities:

• Ensure NPI and commercial products meet applicable GMP requirements.
• Own and oversee NPI product transfers into commercial manufacturing.
• Manage Site QPs and MQA, including batch release, product performance and regulatory support.
• Ensure sterile and aseptic products meet company, customer and regulatory requirements.
• Verify batch manufacture complies with approved marketing authorisations.
• Ensure manufacturing and testing comply with GMP, including EU GMP Annex 1 and FDA requirements.
• Ensure manufacturing and testing processes are appropriately validated.
• Ensure deviations and changes are reviewed, approved and managed in accordance with established procedures.
• Ensure regulatory authorities approve changes requiring marketing or manufacturing authorisation updates.
• Maintain current knowledge of relevant technical, scientific and quality requirements.

Knowledge, Skills and Experience Required for the Role:

• Science degree + pharma/healthcare experience.
• MSc in Industrial Pharmaceutical Science or equivalent, supporting QP eligibility under Article 49 of Directive 2001/83/EC.
• Experience in FDA- and EMA-regulated environments.
• Supervisory/management experience in pharma, biotech or medical device manufacturing.
• Experience in drug product manufacturing, including aseptic filling, visual inspection, solution preparation and sterilisation.
• Strong audit management and regulatory engagement experience.