Senior Quality Assurance Manager

Relocation Package Available within the US

We’re seeking an experienced Senior Quality Assurance Manager to help lead quality operations within a highly regulated pharmaceutical and medical device manufacturing environment. Reporting to the Head of Quality, this role plays a key part in ensuring cGMP compliance, maintaining inspection readiness, and strengthening our Quality Management System (QMS).

If you thrive in FDA-regulated environments and enjoy driving continuous improvement, this is a high-visibility leadership opportunity.

• Lead and manage QA team activities to ensure compliance with cGMP and internal SOPs
• Oversee and maintain the Quality Management System (QMS)
• Ensure timely investigation of OOS results, deviations, complaints, and CAPAs
• Maintain inspection readiness for FDA, EU, and global regulatory audits
• Partner cross-functionally on validation, change control, and process improvements
• Monitor and report quality KPIs to senior leadership
• Support Annual Product Reviews and Quality Review Board activities

• Bachelor’s degree in Chemistry, Microbiology, or related technical field (Master’s preferred)
• 8+ years of pharmaceutical or regulated manufacturing experience
• 2+ years of team leadership or project management experience
• Strong knowledge of 21 CFR Parts 210/211, 21 CFR Part 11, ICH Q7
• Experience with eQMS systems (Track Wise preferred)
• Proven success supporting audits and regulatory inspections
• Strong analytical, root cause analysis, and problem-solving skills
• Certifications such as CQM, CQA, or Six Sigma Black Belt are a plus.