QA Operations Manager
Walker Cole International is partnering with a leading manufacturer to appoint a QA Operations Manager. This role will be responsible for driving Performance Excellence across the site, leading continuous improvement initiatives, and embedding a culture of operational excellence across multiple functions and locations.
Key Responsibilities as the Quality Operations Manager:
- Lead, coach, and develop the QA/QC Operations team, fostering a proactive quality culture across manufacturing.
- Review manufacturing and packaging documentation, making batch release and rejection decisions in line with regulatory requirements.
- Lead deviation investigations, root cause analysis, CAPA implementation, and Annual Product Quality Reviews (APQRs).
- Monitor quality KPIs, identify trends, and drive continuous improvement initiatives across site operations.
- Work cross-functionally with Production, Technical, Supply Chain, and Regulatory teams to support new product introductions, process changes, and validation activities.
- Identify training needs across the quality team, delivering GMP coaching and supporting succession planning.
Skills and experience:
- Demonstrable experience within a Quality Assurance leadership position in a GMP-regulated pharmaceutical manufacturing environment.
- Strong working knowledge of EU and UK GMP requirements, with experience supporting regulatory inspections and audits.
- Experience leading batch review and release activities.
- Excellent leadership, communication, and stakeholder management skills.
- Strong problem-solving abilities with experience leading investigations, CAPAs, and continuous improvement projects.