At a Glance
- Tasks: Manage quality for complex projects and ensure compliance with medical device regulations.
- Company: Join a leading pharmaceutical company focused on innovation and quality.
- Benefits: Enjoy a competitive salary, annual bonus, health insurance, and flexible working arrangements.
- Other info: Great learning opportunities and a supportive work environment await you.
- Why this job: Make a real impact in drug delivery device development while growing your career.
- Qualifications: Expertise in medical device regulations and strong project management skills required.
The predicted salary is between 60000 - 75000 £ per year.
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.
- 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
- 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.
R&D Quality Manager employer: Sandoz International GmbH
As an R&D Quality Manager at Sandoz, you will be part of a dynamic and innovative team dedicated to ensuring the highest quality standards in drug delivery device development. Our commitment to employee growth is reflected in our robust learning and development opportunities, alongside a flexible working environment that promotes work-life balance. With competitive salaries, annual bonuses, and a strong focus on employee recognition, Sandoz stands out as an exceptional employer in the healthcare sector.
