R&D Quality Manager (Medical Devices and/or Combination Products)

Job title:

R&D Quality Manager (Medical Devices and/or Combination Products)

Company:

Novartis

Job description

Job Description Summary 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 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 DevelopmentManages global initiatives; manage complex projects (cross sites, high impact); Due diligence independently.Job DescriptionThis role is being hired in Cambridge, UK and Ljubljana, Slovenia.Your Key Responsibilities:Your responsibilities include, but not limited to:Quality responsible person for the assigned Design History File portfolioSupport 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 an ensure they are re-solved consistently and in accordance with global standards and policies.Release of medical devices and device components of combination products for clinical batch productionRepresent Quality Drug Delivery Device Development in initiatives and cross-divisional projectsPerform or support inspections and audits as requiredApproval of Deviation and OOS/OOE and change Controls in Sandoz systemsApproval in document management systemsComply 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 ManagementProject Management Skills – Critical Negotiations, Influencing Skills and Collaboration across boundariesExcellent communication skills in EnglishYou’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:#SandozSkills Desired Agility, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise

Expected salary

Location

Cambridge

Job date

Sun, 12 Jan 2025 07:21:33 GMT

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