Our client, a leading organisation within the biopharmaceutical industry, is seeking an experienced QA Operations Manager to oversee Quality Assurance activities across sterile manufacturing, New Product Introduction (NPI) and commercial operations.
Reporting to the QA Director, the successful candidate will ensure compliance with GMP and regulatory requirements, oversee product quality and batch release, and support the successful transfer of new products into clinical and commercial manufacturing.
Key Responsibilities
- Oversee QA activities across NPI and commercial manufacturing, ensuring compliance with GMP and regulatory requirements.
- Manage Qualified Person (QP) activities, Manufacturing Quality Assurance and batch certification and release.
- Ensure sterile and aseptic manufacturing processes comply with EU GMP Annex 1, FDA regulations and applicable Marketing Authorisations.
- Support technology transfer, process validation and the progression of new products into commercial manufacturing.
- Oversee deviations, change controls and quality systems, ensuring appropriate assessment, approval and regulatory compliance.
- Liaise with regulatory authorities, including the FDA and HPRA, and collaborate with global Quality, Regulatory Affairs and technical teams.
- Support regulatory submissions, audits, inspections and continuous improvement initiatives.
- Partner with the QA Director and cross-functional teams to achieve site quality and operational objectives.
Qualifications and Experience
- Degree in a scientific discipline, with relevant pharmaceutical or biotechnology industry experience.
- Relevant postgraduate qualification supporting eligibility for Qualified Person (QP) status.
- Experience in an FDA regulated manufacturing environment.
- Previous management or supervisory experience within pharmaceutical or biotechnology manufacturing.
- Strong knowledge of sterile manufacturing processes, ideally including aseptic filling, solution preparation, visual inspection and sterilisation.
- Proven experience in GMP compliance, audit management and regulatory inspections.
- Strong leadership, communication and cross-functional collaboration skills.
If you would like to find out more about this role, reach out to Kellie O Donovan today for a confidential discussion or click the 'apply now' button
