At a Glance
- Tasks: Manage quality projects and ensure compliance in drug delivery device development.
- Company: Join Sandoz, a leader in pioneering access for patients.
- Benefits: Competitive salary, annual bonus, health insurance, and flexible working arrangements.
- Other info: Diverse and inclusive work environment with great learning opportunities.
- Why this job: Make a real impact in healthcare by ensuring quality in innovative medical devices.
- 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.
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: Dormont Manufacturing Co
At Sandoz, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the field of drug delivery device development. Our commitment to employee growth is evident through our comprehensive learning and development opportunities, alongside competitive benefits such as flexible working arrangements and a robust health insurance plan. Join us in our mission to pioneer access for patients while being part of a diverse and inclusive team that values your contributions.
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We think this is how you could land R&D Quality Manager in Cambridge
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We think you need these skills to ace R&D Quality Manager in Cambridge
Some tips for your application 🫡
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How to prepare for a job interview at Dormont Manufacturing Co
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Dormont Manufacturing Co that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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