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
- Establish and maintain the QA Operations organisational structure, including reporting relationships, in collaboration with senior management.
- Plan, organise, and direct day-to-day activities of the QA Operations team, including performance management, training, and development.
- Act as an independent QA subject matter expert, supporting manufacturing, packaging, testing, release, and supply operations.
Quality Systems & Compliance
- Ensure GMP SOPs relevant to QA Operations are authored, reviewed, approved, and effectively implemented, with appropriate training delivered.
- Generate, trend, and monitor QA Operations KPIs, implementing continuous improvement programmes as required.
- Support the Management Review process, including preparation, compilation, and follow-up of quality metrics and actions.
QP Support & Batch Release
- Support QP release and certification of:
- Commercial batches in compliance with Marketing Authorisations
- Investigational Medicinal Products (IMPs) in compliance with Clinical Trial Authorisations and Product Specification Files
- Ensure all batches are manufactured and tested in accordance with cGMP (21 CFR 210/211 and EU Directive 2003/94/EC).
Manufacturing & Operational Quality
- Provide QA oversight for manufacturing, packaging, in-process controls, sampling, swabbing, documentation, and batch record review.
- Ensure Operation Quality activities (IPQA, Documentation Control, Training, Validation) support compliant manufacture and QP certification.
Validation, Training & Vendor Oversight
- Oversee site validation activities, ensuring processes are validated and facilities/equipment are qualified.
- Lead the site GMP training programme, ensuring ongoing compliance and continuous reinforcement of quality standards.
- Evaluate, approve, and maintain oversight of outsourced laboratories, service providers, and raw/packaging material vendors.
Audits, Inspections & Investigations
- Support regulatory and customer audits, ensuring effective preparation, participation, and timely closure of observations.
- Lead and participate in cross-functional investigations, ensuring root cause analysis and effective CAPA implementation.
New Products & Technology Transfer
- Support new product introductions (NPI) and technology transfer activities, ensuring quality requirements are met.
Financial & Shared Services Responsibilities
- Create and manage the QA Operations capital and operating budget.
- Provide quality support to Amneal EU Limited as part of a shared service model, in line with company policies and procedures.
Qualifications & Experience
Essential
- Degree in Science, Pharmacy, Engineering, or related discipline
- Extensive experience in QA Operations within a GMP-regulated pharmaceutical environment
- Strong working knowledge of EU & FDA GMP requirements
- Experience supporting QP certification and batch release
- Proven leadership and people management experience
Desirable
- Experience supporting both commercial and clinical/IMP manufacturing
- Prior involvement in regulatory inspections (HPRA, EMA, FDA, etc.)
- Budget management and strategic QA leadership experience
Key Competencies
- Strong decision-making and problem-solving skills
- Excellent stakeholder and cross-functional collaboration
- High attention to detail and compliance mindset
- Ability to drive continuous improvement in a fast-paced environment
