QA Manager Development (m/f/d)

SANDOZ
Division SANDOZ
Geschäftseinheit Product Dev SZ
Standort Rudolstadt
Funktionsbereich Quality
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 267092BR


Stellenbeschreibung

817 million. That’s how many lives our products touched in 2018. 200 projects currently in clinical development. 16 major approvals last year alone. These are achievements we’re incredibly proud of, but in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

The QA Manager (m/f/d) is part of the Sandoz Development Center (SDC) team, provides quality compliance support and guidance to the Development Project Management respectively the project teams, performs document reviews, supports the supplier evaluation, establishes Quality Agreements and is part of the due diligence team, acts as quality person in the plant for the production of non-commercial batches, supports the dossier review and respective product launches. Assists with reporting of KQIs and Quality Metrics to SDC and Global Quality Management and supports regarding other SDC Quality Compliance activities such as self-inspections and external audit plan preparation as necessary.

Your major accountabilities:
• Support quality related activities in the development center to ensure compliance with systems and policies
• Contribute to the development and life cycle management of drugs and formulations according to § 3 Abs. 2 BApO
• Oversee the product development from a quality perspective and advice the development teams on GMP relevant questions
• Actively provide information on GMP requirements for the manufacture and release of clinical trial supplies to the project teams
• Ensures compliance that each batch of investigational medicinal product has been manufactured and tested in accordance with the legal and registration requirements (e.g. AMG, AMWHV, EG-GMP-Guideline)
• Supports the creation of audit plans for internal and external audits
• Immediately escalates quality and compliance issues to SDC Quality Management



Quality


Mindestanforderungen

• Academic degree in Science (pharmacy, chemistry, biology or similar)
• Minimum 3 years professional experience in quality control (QC) or quality assurance (QA) or quality management (QM) in pharmaceutical industry
• Good knowledge in GMP and regulatory guidelines in pharmaceutical industry
• Fluent in English essential for business, good command in German of advantage
• Scientific, systematic and target oriented approach to work
• Demonstrated ability in comprehensive thinking and implementation skills

Why Novartis?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given the opportunity to explore the power and potential of data and digital. Where you’re empowered to risk failure by taking smart risks. Where you’re encouraged to share new ideas that can open up new ways of making things happen. And where you’re surrounded by teams who are equally determined to transform lives by tackling the world’s toughest medical challenges.

Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

We are Novartis. Join us and help reimagine medicine.



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