The QA Operations Manager is responsible for providing strategic and operational leadership for the QA Operations function, ensuring full compliance with cGMP, regulatory requirements, and company quality standards. This role supports QP certification for commercial and investigational products and drives continuous improvement across manufacturing, packaging, validation, training, and quality systems.
Key Responsibilities
Leadership & QA Operations Oversight
1. Establish and maintain the QA Operations organisational structure, including reporting relationships, in collaboration with senior management.
2. Plan, organise, and direct day-to-day activities of the QA Operations team, including performance management, training, and development.
3. Act as an independent QA subject matter expert, supporting manufacturing, packaging, testing, release, and supply operations.
Quality Systems & Compliance
4. Ensure GMP SOPs relevant to QA Operations are authored, reviewed, approved, and effectively implemented, with appropriate training delivered.
5. Generate, trend, and monitor QA Operations KPIs, implementing continuous improvement programmes as required.
6. Support the Management Review process, including preparation, compilation, and follow-up of quality metrics and actions.
QP Support & Batch Release
7. Support QP release and certification of:Commercial batches in compliance with Marketing AuthorisationsInvestigational Medicinal Products (IMPs) in compliance with Clinical Trial Authorisations and Product Specification Files
8. Ensure all batches are manufactured and tested in accordance with cGMP (21 CFR / and EU Directive /94/EC).
Manufacturing & Operational Quality
9. Provide QA oversight for manufacturing, packaging, in-process controls, sampling, swabbing, documentation, and batch record review.
10. Ensure Operation Quality activities (IPQA, Documentation Control, Training, Validation) support compliant manufacture and QP certification.
Validation, Training & Vendor Oversight
11. Oversee site validation activities, ensuring processes are validated and facilities/equipment are qualified.
12. Lead the site GMP training programme, ensuring ongoing compliance and continuous reinforcement of quality standards.
13. Evaluate, approve, and maintain oversight of outsourced laboratories, service providers, and raw/packaging material vendors.
Audits, Inspections & Investigations
14. Support regulatory and customer audits, ensuring effective preparation, participation, and timely closure of observations.
15. Lead and participate in cross-functional investigations, ensuring root cause analysis and effective CAPA implementation.
New Products & Technology Transfer
16. Support new product introductions (NPI) and technology transfer activities, ensuring quality requirements are met.
Financial & Shared Services Responsibilities
17. Create and manage the QA Operations capital and operating budget.
18. Provide quality support to Amneal EU Limited as part of a shared service model, in line with company policies and procedures.
Qualifications & Experience
Essential
19. Degree in Science, Pharmacy, Engineering, or related discipline
20. Extensive experience in QA Operations within a GMP-regulated pharmaceutical environment
21. Strong working knowledge of EU & FDA GMP requirements
22. Experience supporting QP certification and batch release
23. Proven leadership and people management experience
Desirable
24. Experience supporting both commercial and clinical/IMP manufacturing
25. Prior involvement in regulatory inspections (HPRA, EMA, FDA, etc.)
26. Budget management and strategic QA leadership experience
Key Competencies
27. Strong decision-making and problem-solving skills
28. Excellent stakeholder and cross-functional collaboration
29. High attention to detail and compliance mindset
30. Ability to drive continuous improvement in a fast-paced environment