At a Glance
- Tasks: Manage quality for innovative medical devices and ensure compliance with industry standards.
- Company: Join Sandoz, a leader in pioneering patient access and quality healthcare solutions.
- Benefits: Enjoy competitive salary, annual bonus, health insurance, and flexible working arrangements.
- Other info: Be part of a diverse team committed to inclusion and professional growth.
- Why this job: Make a real impact in healthcare by ensuring the quality of life-changing products.
- Qualifications: Expertise in medical device regulations and strong project management skills required.
The predicted salary is between 60000 - 75000 £ per year.
At Sandoz, our purpose is pioneering access for patients. The Quality Manager role manages complex projects or late‑phase projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards, ensuring compliance with cGMP in Drug Delivery Device Development.
Responsibilities
- Act as Quality Responsible Person for the assigned Design History File portfolio
- Support quality aspects of development projects and processes assigned to the department and assure compliance with medical device and combination product regulations, good pharmaceutical practices, and Sandoz internal standards
- Support quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies
- Release 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
- Approve deviations, OOS/OOE, and change controls in Sandoz systems
- Approve documents 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
- Expert knowledge in Medical Device and Combination product regulations (EU MDR, FDA CFR Part 820 and Part 4, ISO 13485)
- Functional breadth in Quality Management, Change Control and Audit Management
- Project management skills
- Critical negotiation, influencing skills and collaboration across boundaries
- Excellent communication skills in English
Desired Skills
- Change Control
- Influencing skills
- Knowledge of CAPA, QA (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA)
- SOP (Standard Operating Procedure)
Benefits
- Competitive salary
- Annual bonus
- Pension scheme
- Health insurance
- 24 days annual leave
- Flexible working arrangements
- Employee recognition scheme
- Learning and development opportunities
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment with diverse teams that are representative of the patients and communities we serve.
R&D Quality Manager in Cambridge employer: GB69 (FCRS = GB069) Sandoz Ltd.
At Sandoz, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. As an R&D Quality Manager, you will benefit from competitive salaries, flexible working arrangements, and extensive learning and development opportunities, all while contributing to our mission of pioneering access for patients. Our commitment to diversity and inclusion ensures a supportive environment where every employee can thrive and grow.
Contact Details:
GB69 (FCRS = GB069) Sandoz Ltd. Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land R&D Quality Manager in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Sandoz. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s values and projects. Show us how your experience aligns with their mission of pioneering access for patients. We love candidates who are genuinely interested!
✨Tip Number 3
Don’t just wait for job openings; be proactive! Check our website regularly and apply directly. It shows initiative and gives you a better chance to stand out from the crowd.
✨Tip Number 4
Practice your communication skills. Whether it’s discussing quality management or project oversight, being clear and confident will help you make a great impression during interviews.
We think you need these skills to ace R&D Quality Manager in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the R&D Quality Manager role. Highlight your experience with medical device regulations and quality management. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management in drug delivery devices. Let us know how you can contribute to our mission of pioneering access for patients.
Showcase Relevant Experience:When detailing your work history, focus on projects that demonstrate your expertise in compliance and quality assurance. We love seeing examples of how you've tackled challenges in previous roles!
Apply Through Our Website:Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at GB69 (FCRS = GB069) Sandoz Ltd.
✨Know Your Regulations
Make sure you brush up on your knowledge of Medical Device and Combination product regulations, especially EU MDR and FDA CFR. Being able to discuss these confidently will show that you’re not just familiar with the basics but can navigate complex regulatory landscapes.
✨Showcase Your Project Management Skills
Prepare examples from your past experiences where you successfully managed projects or resolved quality issues. Highlight your project management skills and how they align with the responsibilities of the R&D Quality Manager role.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. Since excellent communication skills are essential for this role, consider doing mock interviews with a friend to refine your ability to convey complex information in an understandable way.
✨Demonstrate Collaboration
Be ready to discuss how you've worked across different teams or departments in previous roles. Emphasise your influencing skills and how you’ve successfully navigated challenges through collaboration, as this is key for the position at Sandoz.
