Quality Operations Manager
Core
Lead quality operations and regulatory compliance for a biopharma company, overseeing batch manufacturing records, deviation management, and customer quality agreements.
Role type
Senior Quality Operations Manager
Builds
Quality systems, compliance frameworks, and operational resilience across manufacturing sites
Domain
Biopharmaceuticals / Quality Assurance / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, deviation management, team leadership, regulatory audit support, cross-functional collaboration, process improvement, stakeholder management, batch release oversight, EudraLex Vol 4 expertise, serialisation knowledge
Preferred skills
Qualified Person Function experience, regulatory inspection hosting, primary and secondary packaging process expertise
Technologies
GMP systems, EudraLex Vol 4, serialisation tools
Responsibilities
Lead quality operations and batch manufacturing record generation; Partner with Quality Managers to drive continuous improvement; Establish cross-functional quality training frameworks; Own governance of quality documentation systems; Authorize and oversee deviation management and investigation protocols; Provide direction and leadership to the quality operations team (~10 direct reports); Execute GEMBA leadership walks to assess operational standards; Lead high-level customer engagement and audit processes; Establish technical expertise in packaging and quality processes
Seniority
Senior, hands-on IC with team management
