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- Tasks: Lead quality management for medical device projects and ensure compliance with regulations.
- Company: Join Sandoz, a global leader in sustainable medicines, transforming healthcare for millions.
- Benefits: Enjoy competitive salary, flexible working, health insurance, and 24 days' leave.
- Why this job: Be part of a collaborative culture that values personal growth and innovation in healthcare.
- Qualifications: Expertise in medical device regulations and strong project management skills required.
- Other info: This role is based in Cambridge, UK, and Ljubljana, Slovenia.
The predicted salary is between 43200 - 72000 £ per year.
R&D Quality Manager (Medical Devices and/or Combination Products)
Join to apply for the R&D Quality Manager (Medical Devices and/or Combination Products) role at Sandoz UK & Ireland.
Job Description
Sandoz is undergoing an exciting transformation as a global leader in sustainable Biosimilar and Generic medicines. We offer unique professional and personal growth opportunities.
The Quality Manager oversees complex projects and processes supporting departmental objectives, ensuring compliance with cGMP in Drug Delivery Device Development. The role manages global initiatives and cross-site projects. This position is based in Cambridge, UK, and Ljubljana, Slovenia.
Key Responsibilities
- Serve as the quality responsible person for the Design History File portfolio.
- Support quality aspects of development projects, ensuring compliance with medical device and combination product regulations, good pharmaceutical practices, and internal standards.
- Address quality problems and technical issues, ensuring resolution aligns with global standards.
- Release medical devices and components for clinical batch production.
- Represent Quality Drug Delivery Device Development in initiatives and cross-divisional projects.
- Participate in inspections and audits as needed.
- Approve deviations, OOS/OOE, change controls, and documentation within Sandoz systems.
- Adhere to internal and external quality and safety guidelines.
Essential Requirements
- Expertise in Medical Device and Combination Product regulations (EU MDR, FDA CFR Part 820 and Part 4, ISO 13485).
- Broad knowledge in Quality Management, Change Control, and Audit Management.
- Strong project management, negotiation, influencing, and collaboration skills.
- Excellent English communication skills.
Benefits
Competitive salary, annual bonus, pension scheme, health insurance, 24 days\’ leave, flexible working, recognition programs, and development opportunities.
Why Sandoz?
As a leader in generics and biosimilars, Sandoz provided treatments for over 900 million patients in 2024. We invest in innovation, production, and partnerships to expand access to affordable, high-quality medicines. Our culture is collaborative, inclusive, and supportive of personal growth and flexible careers.
Commitment to Diversity & Inclusion
We strive to create an inclusive environment with diverse teams reflecting the communities we serve.
Additional Information
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Research, Analysis, IT
- Industry: Pharmaceutical Manufacturing
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R&D Quality Manager (Medical Devices and/or Combination Products) employer: Sandoz UK & Ireland
Contact Detail:
Sandoz UK & Ireland Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land R&D Quality Manager (Medical Devices and/or Combination Products)
✨Tip Number 1
Familiarise yourself with the specific regulations mentioned in the job description, such as EU MDR and FDA CFR Part 820. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to quality management in medical devices.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in quality management. Engaging with them can provide insights into the role and may even lead to referrals, which can significantly boost your chances of landing an interview.
✨Tip Number 3
Prepare to discuss your project management skills in detail. Since the role involves overseeing complex projects, be ready to share examples of how you've successfully managed similar initiatives, highlighting your negotiation and collaboration skills.
✨Tip Number 4
Stay updated on the latest trends and innovations in the pharmaceutical manufacturing sector. Being knowledgeable about current developments can help you stand out during interviews and show that you're genuinely interested in contributing to Sandoz's mission.
We think you need these skills to ace R&D Quality Manager (Medical Devices and/or Combination Products)
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the R&D Quality Manager position. Make sure you understand the key responsibilities and essential requirements, especially regarding compliance with medical device regulations.
Tailor Your CV: Customise your CV to highlight relevant experience in quality management, project management, and knowledge of medical device regulations. Use specific examples that demonstrate your expertise in these areas.
Craft a Compelling Cover Letter: Write a cover letter that connects your skills and experiences directly to the job requirements. Emphasise your understanding of cGMP and your ability to manage complex projects effectively.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a quality management role.
How to prepare for a job interview at Sandoz UK & Ireland
✨Know Your Regulations
Familiarise yourself with the key regulations related to medical devices and combination products, such as EU MDR and FDA CFR Part 820. Being able to discuss these in detail will demonstrate your expertise and understanding of the industry standards.
✨Showcase Project Management Skills
Prepare examples of past projects where you successfully managed quality aspects. Highlight your project management skills, especially in cross-site initiatives, as this role requires strong collaboration and negotiation abilities.
✨Prepare for Technical Questions
Expect technical questions related to quality management, change control, and audit management. Brush up on your knowledge in these areas and be ready to provide specific examples of how you've addressed quality problems in the past.
✨Communicate Clearly
Since excellent English communication skills are essential, practice articulating your thoughts clearly and concisely. This will help you convey your ideas effectively during the interview and show that you can represent the Quality Drug Delivery Device Development team well.
