R&D Quality Lead — Medical Devices & Comb. Products

Sandoz UK & Ireland; Cambridge; Hybride; GBP 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Pension scheme

Health insurance

24 days leave

Flexible working

Employee recognition scheme

Learning & development

Résumé du poste

Sandoz UK & Ireland is seeking a Quality Manager to lead complex projects and ensure cGMP compliance in Drug Delivery Device Development. You will manage the Design History File portfolio and drive quality across development programs, ensuring alignment with Medical Device and Combination Product regulations.

You’ll collaborate across functions, lead inspections and audits, and support deviation and change control processes while upholding Sandoz standards and a commitment to patient safety.

Qualifications

• Expert knowledge in Medical Device and Combination product regulations (EU MDR, FDA CFR Part 820 and Part 4, ISO 13485)
• Functional breadth - Quality Management, Change Control and Audit Management
• Project management and cross-functional collaboration skills

Responsabilités

• Quality responsible person for the assigned Design History File portfolio
• Support quality aspects of development projects and assure compliance with Medical devices as well as Combination product regulations, good pharmaceutical practices and Sandoz internal standards
• Support quality problems and technical matters and ensure they are re-solved consistently and in accordance with global standards and policies
• Release of medical devices and device components of combination products for clinical batch production Represent Quality Drug Delivery Device Development in initiatives and cross-divisional projects
• Perform or support inspections and audits as required Approval of Deviation and OOS/OOE and change Controls in Sandoz systems
• Approval in document management systems
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.)

Connaissances

Quality Management

Change Control

Audit Management

Project Management

English communication

Description du poste

Sandoz UK & Ireland is seeking a Quality Manager to lead complex projects and ensure cGMP compliance in Drug Delivery Device Development. You will manage the Design History File portfolio and drive quality across development programs, ensuring alignment with Medical Device and Combination Product regulations.

You’ll collaborate across functions, lead inspections and audits, and support deviation and change control processes while upholding Sandoz standards and a commitment to patient safety.