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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. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!
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. 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)
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. 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 to connect with potential colleagues at Sandoz and gain insights into their company culture and expectations.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed complex projects or resolved quality issues in previous roles. Highlight your project management skills and ability to collaborate across teams, as these are crucial for the R&D Quality Manager position.
✨Tip Number 4
Showcase your communication skills by engaging with Sandoz on social media platforms. Comment on their posts or share relevant articles to demonstrate your interest in the company and its mission, making you more memorable to the hiring team.
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, particularly around quality management and compliance with medical device regulations.
Tailor Your CV: Customise your CV to highlight relevant experience in quality management, project management, and compliance with medical device regulations. Use specific examples that demonstrate your expertise in areas such as EU MDR and FDA CFR.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for joining Sandoz during this transformative period. Mention how your skills align with their goals and culture.
Highlight Communication Skills: Since excellent communication skills are essential for this role, ensure that your application reflects your ability to communicate effectively. Use clear and concise language, and consider including examples of successful collaboration across teams.
How to prepare for a job interview at Sandoz UK & Ireland
✨Understand the Regulatory Landscape
Familiarise yourself with the key regulations related to Medical Devices and Combination products, such as EU MDR and FDA CFR Part 820. Being able to discuss these regulations confidently will demonstrate your expertise and commitment to quality management.
✨Showcase Project Management Skills
Prepare examples of complex projects you have managed in the past, highlighting your critical negotiation and influencing skills. This will help illustrate your ability to handle cross-divisional initiatives effectively.
✨Emphasise Communication Skills
Since excellent communication is essential for this role, practice articulating your thoughts clearly and concisely. Be ready to discuss how you've successfully collaborated with diverse teams in previous roles.
✨Align with Sandoz's Values
Research Sandoz's commitment to diversity, inclusion, and sustainability. Be prepared to discuss how your personal values align with theirs and how you can contribute to their ambitious goals as a new company.
