R&D Quality Manager

Sandoz UK & Ireland; Cambridge; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Pension scheme

Health insurance

24 days leave

Flexible working

Employee recognition scheme

Learning & development

Job summary

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

Responsibilities

• 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.)

Skills

Quality Management

Change Control

Audit Management

Project Management

English communication

Job description

The Quality Manages complex projects or late phase projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards.

Ensures that compliance with cGMP is maintained in Drug Delivery Device Development.

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Quality responsible person for the assigned Design History File portfolio
• Support quality aspects of development projects and/or processes assigned to department 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 an 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.).

Essential Requirements

What you’ll bring to the role:

• 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 Skills - Critical Negotiations, Influencing Skills and Collaboration across boundaries
• Excellent communication skills in English

You’ll Receive

Competitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz