Sterile QA Operations Lead

Inova Group; Sligo; On-site; EUR 75,000 - 110,000; Full time

Job summary

Inova Group in Ireland seeks a QA Operations Manager to oversee Quality Assurance for sterile products, including NPIs and commercial batches, ensuring compliance with GMP, regulatory requirements and Marketing Authorisations.

Reporting to the QA Director, you will manage QPs and MQA oversight, drive successful NPIs transfer, ensure batch release, and collaborate with Regulatory Affairs to support product filings and ongoing compliance across site operations.

Qualifications

• Degree-level qualification in a science discipline with relevant experience in healthcare/pharmaceutical industry.
• MSc enabling Qualified Person (QP) status under Article 49 of Directive 2001/83/EC.
• Significant experience in FDA/EMA-regulated pharmaceutical environment.
• Supervisory/management experience in a manufacturing-related function.
• Experience with aseptic filling, visual inspection, solution preparation and sterilisation is desirable.
• Proven audit management and regulatory interactions.
• Strong knowledge of GMP, quality systems and regulatory requirements in sterile manufacturing.

Responsibilities

• Oversee QA activities for sterile NPIs and Commercial products.
• Ensure NPIs are transferred into commercial manufacturing processes.
• Oversee QPs and MQA including batch release and regulatory support.
• Ensure sterile products meet end-user, regulatory, and MA requirements.
• Verify batches manufactured per Marketing Authorisation.
• Ensure GMP compliance including EU GMP Annex 1 and FDA regs.
• Validate critical manufacturing and testing processes.
• Assess and manage deviations, exceptions, and changes through quality systems.
• Manage regulatory variations from manufacturing or MA changes.
• Maintain up-to-date knowledge in technical and regulatory developments.
• Liaise with global QA and Regulatory Affairs and authorities (FDA, HPRA, others).
• Provide QA support for product filings.
• Support transfer of NPIs to site and progression into clinical/commercial manufacturing.
• Collaborate with QA Director, QC and Quality Systems to meet objectives.

Skills

GMP knowledge

Quality systems

Regulatory interactions

Leadership

Education

MSc in Industrial Pharmaceutical Science

Science degree

Job description

Inova Group in Ireland seeks a QA Operations Manager to oversee Quality Assurance for sterile products, including NPIs and commercial batches, ensuring compliance with GMP, regulatory requirements and Marketing Authorisations.

Reporting to the QA Director, you will manage QPs and MQA oversight, drive successful NPIs transfer, ensure batch release, and collaborate with Regulatory Affairs to support product filings and ongoing compliance across site operations.