Senior QA Manager
The Senior QA Manager provides strategic and operational leadership for QA Operations, ensuring full compliance with cGMP, regulatory requirements, and internal quality standards. The role supports QP certification for commercial and investigational products while driving continuous improvement across manufacturing and quality systems.
Responsibilities
- Provide strategic and day-to-day leadership of the QA Operations function, including organisational structure, performance management, training, and team development
- Act as an independent QA subject matter expert supporting manufacturing, packaging, testing, release, and supply operations
- Ensure GMP SOPs relevant to QA Operations are authored, maintained, approved, and effectively implemented with appropriate training
- Generate, trend, and monitor QA Operations KPIs and lead continuous improvement initiatives
- Support and contribute to Management Review activities, including preparation and follow-up of quality metrics and actions
- Support QP certification and batch release for commercial and investigational products in line with Marketing Authorisations, CTAs, and Product Specification Files
- Ensure all manufacturing and testing activities comply with EU and FDA cGMP requirements (21 CFR 210/211 and EU Directive 2003/94/EC)
- Provide QA oversight of manufacturing, packaging, in-process controls, sampling, documentation, and batch record review
- Oversee validation, qualification, documentation control, training, and IPQA activities to support compliant manufacture
- Lead site GMP training programmes to ensure ongoing compliance and quality culture reinforcement
- Evaluate, approve, and maintain oversight of outsourced laboratories, service providers, and material vendors
- Support regulatory and customer audits, inspections, and the timely closure of observations
- Lead and participate in cross-functional investigations, ensuring robust root cause analysis and effective CAPA implementation
- Support new product introductions and technology transfer activities from a quality perspective
- Create and manage QA Operations operating and capital budgets
Requirements
- Degree in Science, Pharmacy, Engineering, or a related discipline
- Extensive experience in QA Operations within a GMP-regulated pharmaceutical environment
- Strong working knowledge of EU and FDA GMP requirements
- Demonstrated experience supporting QP certification and batch release activities
- Proven leadership and people management capability
- Experience supporting both commercial and clinical or IMP manufacturing is desirable
- Prior involvement in regulatory inspections such as HPRA, EMA, or FDA is desirable
- Experience in budget management and strategic QA leadership is advantageous
- Strong decision-making, problem-solving, and risk-based thinking skills
- Excellent stakeholder engagement and cross-functional collaboration abilities
- High attention to detail with a strong compliance and continuous improvement mindset
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