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- Tasks: Manage quality for medical devices and ensure compliance with regulations.
- Company: Sandoz is a global leader in sustainable biosimilar and generic medicines.
- Benefits: Enjoy competitive salary, annual bonus, flexible working, and learning opportunities.
- Why this job: Be part of a transformative journey impacting millions of patients globally.
- Qualifications: Expertise in medical device regulations and strong project management skills required.
- Other info: Join a diverse team in an agile, collaborative culture focused on personal growth.
The predicted salary is between 43200 - 72000 £ per year.
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.
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 and manages global initiatives; manages complex projects (cross sites, high impact); due diligence independently.
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 (UK).
- 24 days annual leave (UK).
- Flexible working arrangements (UK).
- Employee recognition scheme.
- Learning and development opportunities.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape!
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.
Join our Sandoz Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com).
R&D Quality Manager 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
✨Tip Number 1
Familiarise yourself with the latest regulations and standards in Medical Device and Combination products, such as EU MDR and FDA CFR Part 820. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the quality management and medical device sectors. Attend industry conferences or webinars where you can meet people from Sandoz or similar companies. Building these connections can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed complex projects or resolved quality issues in previous roles. Use the STAR method (Situation, Task, Action, Result) to structure your responses, showcasing your problem-solving skills and project management experience.
✨Tip Number 4
Research Sandoz's recent initiatives and projects related to quality management and drug delivery devices. Being knowledgeable about their current focus areas will allow you to tailor your discussions and show genuine interest in contributing to their goals.
We think you need these skills to ace R&D Quality Manager
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the R&D Quality Manager position at Sandoz. Make sure you understand the key responsibilities and essential requirements, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience with Medical Device and Combination product regulations, as well as your project management skills. Use specific examples to demonstrate how your background aligns with the role's requirements.
Showcase Communication Skills: Since excellent communication skills in English are essential for this role, ensure that your application is well-written and free of errors. Consider having someone review your documents to provide feedback on clarity and professionalism.
Express Enthusiasm for Sandoz: In your cover letter, convey your excitement about the opportunity to join Sandoz during this transformative period. Mention how you align with their commitment to diversity and inclusion, and express your desire to contribute to their mission of providing sustainable medicines.
How to prepare for a job interview at Sandoz UK & Ireland
✨Showcase Your Regulatory Knowledge
Make sure to highlight your expertise in Medical Device and Combination product regulations during the interview. Familiarise yourself with EU MDR, FDA CFR Part 820, and ISO 13485, as these are crucial for the role.
✨Demonstrate Project Management Skills
Be prepared to discuss your project management experience, especially in managing complex projects. Use specific examples to illustrate your critical negotiation and influencing skills, as well as your ability to collaborate across boundaries.
✨Prepare for Quality Compliance Questions
Expect questions related to compliance with cGMP and good pharmaceutical practices. Be ready to explain how you have ensured quality standards in past roles and how you would approach quality problems at Sandoz.
✨Communicate Effectively
Since excellent communication skills are essential for this position, practice articulating your thoughts clearly and confidently. Consider how you can convey complex information simply, as this will be key in cross-divisional projects.
