At a Glance
- Tasks: Manage quality for innovative medical devices and ensure compliance with industry standards.
- Company: Join Sandoz, a global leader in affordable healthcare solutions.
- Benefits: Enjoy competitive salary, annual bonus, flexible working, and development opportunities.
- Other info: Be part of a diverse team in a collaborative environment focused on personal growth.
- Why this job: Make a real impact on global health by ensuring quality in life-saving products.
- Qualifications: Expertise in medical device regulations and strong project management skills.
The predicted salary is between 60000 - 75000 £ per year.
At Sandoz, our Purpose is pioneering access for patients.
The Quality Manager 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:
- 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 and ensure they are resolved 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.).
What you’ll bring to the role:
Essential Requirements:
- 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.
Skills Desired: Change Control, Influencing Skills, Knowledge Of CAPA, QA (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, SOP (Standard Operating Procedure).
R&D Quality Manager in Cambridge employer: Sandoz
At Sandoz, we pride ourselves on being a leading employer in the healthcare sector, offering a dynamic and inclusive work environment that fosters personal and professional growth. Our commitment to pioneering access to medicines is matched by our dedication to employee well-being, with competitive salaries, flexible working arrangements, and robust learning opportunities. Join us in making healthcare fairer and faster while enjoying a collaborative culture that values diversity and innovation.
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 folks in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. This will help you stand out and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice your responses to common interview questions, but keep it natural. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your relevant experience in quality management and compliance.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can go a long way in keeping you top of mind. And remember, apply through our website for the best chance at landing that R&D Quality Manager role!
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 speaks directly 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 what we’re looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to tell us why you’re passionate about quality management in drug delivery devices. Share specific examples of your past successes that relate to the job description.
Showcase Your Communication Skills:Since excellent communication is key for this role, make sure your application is clear and concise. We appreciate well-structured documents that are easy to read and understand. It reflects your attention to detail!
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Sandoz
✨Know Your Regulations
Make sure you brush up on your knowledge of Medical Device and Combination product regulations, especially EU MDR and FDA CFR Part 820. Being able to discuss these confidently will show that you're not just familiar with the standards but can also apply them in real-world scenarios.
✨Showcase Your Project Management Skills
Prepare examples from your past experiences where you've successfully managed complex projects or quality issues. Highlight your critical negotiation and influencing skills, as well as how you collaborated across different teams to achieve project goals.
✨Communicate Clearly
Since excellent communication skills are essential for this role, practice articulating your thoughts clearly and concisely. You might want to do a mock interview with a friend or family member to get comfortable discussing your experiences in English.
✨Be Ready for Technical Questions
Expect questions related to quality management, change control, and audit management. Prepare to discuss specific situations where you’ve dealt with quality problems or compliance issues, and be ready to explain how you resolved them according to global standards.
