345959BR
Jun 14, 2022
Germany

Job Description

1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and outstanding expertise in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar.

Job purpose:

The (Senior) Quality Manager is responsible to manage a portfolio of assigned Medical Device/ Drug Device combination projects to assure cGMP Compliance with medical device specific regulations (ISO 13485:2016, EU MDR and 21 CFR 820) and internal Novartis standards for Sandoz Medical Device development products under submission and Life Cycle Management activities. He/She ensures the quality specific tasks of a Design History File and follow-up including supporting medical device reporting to regulatory authorities.

Your responsibilities :

• Manage a portfolio of assigned Sandoz Medical Device/ Drug Device Combination projects from Quality perspective and provide functional expertise in the area of responsibility for medical devices and combination products in cross-functional project teams
• Quality responsible person for the assigned Design History File portfolio
• Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients and represent Medical Device Quality in initiatives and cross-divisional projects
• Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting
• Create, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance
• Perform or support inspections and audits as required and provide support to line functions in GMP compliance related issues in the area of expertise (e.g. Medical Device standards)
• Support project management functions as a sub-team member in preparation for PAI Inspection and critical Quality aspects
• Periodic Review and Reporting of Compliance Status and Quality Compliance KPIs, CAPAs for assigned projects

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• Graduate in Engineering e.g. Medical Device engineering/ Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
• Project Management experience (e.g. PMP)
• At least 3 years of relevant experience
• Sound scientific, technical and regulatory knowledge in Medical Device area (ISO 13485:2016, EU MDR and 21 CFR 820) is desirable
• Ability to influence people, negotiate and communicate
• Experiences with health authorities and notified bodies
• Good compliance knowledge of cGMP, working knowledge of medical device and combination product regulations, standards and guidelines
• Good knowledge of medical device compliance for development and life-cycle management
• Excellent organizational and project management as well digitalization skills
• Good and proven ability to analyze and evaluate cGMP compliance
• English fluent in speaking / writing

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:

Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
QA GDD
Germany
Holzkirchen (near Munich)
Quality
Full Time
Regular
No
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345959BR

Senior Quality Manager (d/f/m) limited till September 2024

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