John Chandler Email and Phone Number

• All of the Quality Specialist Role mentioned below plus:• Management of a team of Quality Specialists• Quality Program creation Management CMs, Innovation & Suppliers• Key member of EU leadership team, representing the quality agenda• Ensures implementation and on-going compliance to requirements of category / technology GMP that are applicable to the sites.• Key Member of the Global Quality Collaborative Manufacturing Community of Practice• Ensuring Quality team has level of required skills and knowledge as appropriate to support site quality programs• Providing Quality leadership to influence Quality culture through visibility and coaching of cross-functional leadership across the business• Coordination and content creation for partner learning events• Define and create supplier requirements for packaging materials• Introduction and coordination of the Launch Monitoring Plan programme• Ensure Quality representation and early involvement in the selection of new Suppliers and CMs• Quality sign off SLAs and supplier contracts-RCA / CAPA

• Procedural & GMP Audits at Collaborative Manufacturers• Management of CAPA through Veeva system• Audit Schedule Management for Europe• Risk segmentation and scoring of Collaborative Manufacturing Sites• Regular performance connects with CM points of contact• Quality representation on innovation projects at Collaborative Manufacturers• Facilitation of Risk Management• RCA & CAPA for non conformances• Score Card and KPI reporting• HC Collaborative Manufacturing Leadership Team• Onboarding and integration of New Collaborative Manufacturers

Innovation QualityRisk ManagementImplementation lead ISO13485Management of the Medical Device QMS