QA Operations Manager

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

QA Operations Manager

Reporting to the QA Director, the QA Operations Manager will oversee Quality Assurance activities for sterile products, including New Product Introduction (NPI) and Commercial products, ensuring they are manufactured, filled and released in compliance with GMP, regulatory requirements and applicable Marketing Authorisations.

Main Duties & Responsibilities

• Ensure all NPI and Commercial products are manufactured in accordance with relevant GMP requirements.
• Own and oversee the effective transfer of NPIs into commercial manufacturing processes.
• Manage and provide oversight of Qualified Persons (QPs) and Manufacturing Quality Assurance (MQA), including NPI and Commercial batch release, product performance and regulatory support.
• Ensure sterile and aseptic products meet the requirements of end users, Regulatory Authorities and the organisation.
• Verify that batches are manufactured in accordance with the relevant Marketing Authorisation.
• Ensure manufacturing complies with applicable GMP requirements, including EU GMP Annex 1 and FDA regulations.
• Ensure critical manufacturing and testing processes are appropriately validated, taking account of actual production conditions and manufacturing records.
• Ensure deviations, exceptions and planned changes are appropriately assessed, authorised and managed through established quality systems.
• Ensure regulatory variations arising from changes to manufacturing or Marketing Authorisations are appropriately managed and submitted.
• Maintain up-to-date knowledge and experience in relevant technical, scientific and quality management developments.
• Liaise with global Quality Assurance and Regulatory Affairs teams, as well as relevant regulatory authorities including the FDA, HPRA and other applicable bodies.
• Provide QA and regulatory support for product filings.
• Ensure effective transfer of NPIs to site and progression into clinical and commercial manufacturing.
• Work closely with the QA Director, Quality Control and Quality Systems teams to achieve quality, regulatory, customer service and business objectives.

Qualifications & Experience

• Degree-level qualification in a science discipline with relevant experience in the healthcare or pharmaceutical industry.
• MSc in Industrial Pharmaceutical Science or a similar recognised qualification enabling Qualified Person (QP) status under Article 49 of Directive 2001/83/EC.
• Significant industrial experience within an FDA- and EMA-regulated pharmaceutical environment.
• Previous supervisory and management experience within a manufacturing-related function in a biotechnology, pharmaceutical or medical device organisation.
• Experience with drug product/substance manufacturing processes, including aseptic filling, visual inspection, solution preparation and sterilisation operations, is desirable.
• Proven experience in audit management and regulatory interactions.
• Strong knowledge of GMP, quality systems and regulatory requirements within a sterile/aseptic manufacturing environment.