Role Overview
The Senior QA Manager provides strategic and operational leadership for QA Operations, ensuring full compliance with cGMP, regulatory requirements, and internal quality standards. This role partners closely with Manufacturing, Packaging, Validation, and Supply Chain to support QP certification of commercial and investigational products and to drive continuous improvement across site quality systems.
Key Responsibilities
Leadership & QA Operations
- Build and maintain a high-performing QA Operations organisation, including structure, resourcing, and succession planning, in collaboration with senior leadership.
- Lead, coach, and develop the QA Operations team, embedding a strong quality culture and accountability mindset.
- Act as an independent QA authority supporting manufacturing, packaging, testing, release, and supply operations.
Quality Systems & Compliance
- Ensure QA Operations SOPs are authored, maintained, and effectively implemented, with robust training and adherence across site functions.
- Establish, trend, and report QA Operations KPIs, driving continuous improvement initiatives based on data and risk.
- Support Management Review processes through preparation of quality metrics, insights, and follow-up actions.
QP Support & Batch Release
- Support QP certification and release of:
- Commercial batches in line with Marketing Authorisations
- Investigational Medicinal Products (IMPs) in line with Clinical Trial Authorisations and Product Specification Files
- Ensure all batches are manufactured and tested in compliance with cGMP, including 21 CFR Parts 210/211 and EU GMP requirements.
Manufacturing & Operational Quality
- Provide QA oversight of manufacturing and packaging operations, including in-process controls, sampling, swabbing, documentation practices, and batch record review.
- Ensure IPQA, Documentation Control, Training, and Validation activities effectively support compliant manufacture and QP certification.
Validation, Training & Vendor Oversight
- Oversee site validation programmes to ensure processes are validated and facilities/equipment are qualified and maintained in a compliant state.
- Lead the site GMP training strategy, ensuring ongoing compliance and continuous reinforcement of quality standards.
- Approve and maintain oversight of external laboratories, service providers, and raw/packaging material suppliers.
Audits, Inspections & Investigations
- Lead site readiness and actively support regulatory and customer inspections, ensuring timely and effective closure of observations.
- Drive cross-functional investigations, ensuring robust root cause analysis and sustainable CAPA implementation.
New Product Introduction & Technology Transfer
- Provide quality leadership for NPI and technology transfer activities, ensuring regulatory and quality requirements are embedded from design through routine manufacture.
Financial & Shared Services
- Develop and manage the QA Operations operating and capital budgets.
- Provide QA support to other business locations within a shared services model, in line with company policies and governance.
Qualifications & Experience
Essential
- Degree in Science, Pharmacy, Engineering, or a related discipline
- Significant experience in QA Operations within a GMP-regulated pharmaceutical environment
- Strong working knowledge of EU and FDA GMP
- Demonstrated experience supporting QP certification and batch release
- Proven people leadership and team development experience
Desirable
- Experience across both commercial and clinical/IMP manufacturing
- Direct involvement in regulatory inspections (e.g., HPRA, EMA, FDA)
- Budget ownership and strategic QA leadership experience
Key Competencies
- Strong judgement, decision-making, and problem-solving capability
- Excellent cross-functional communication and stakeholder management
- High attention to detail with a pragmatic compliance mindset
- Ability to lead change and drive continuous improvement in a fast-paced environment
