QA Operations Manager

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.