348035BR
Jul 11, 2022
Germany

Job Description

100! and more - this is the number of external manufacturing sites producing Novartis products that our External Supplier Operations (ESO) Barleben QA Team is managing. Being part of it means you will be within an international team dealing with a lot of different type of products as well as attractive tasks.

Your key responsibilities:
Your responsibilities include, but not limited to:
• Single Point of Contact for all quality related activities (e.g., change control, complaints, deviation, APQR, stability reports, etc.) at External Supplier (QA oversight)
• Responsible to perform and maintain Supplier Qualification process including but not limited to supplier approval, supplier maintenance, supplier exit, quality risk assessment, QA agreement
• Ensure that all related GMP activities are in compliance with Novartis Quality Manual, Quality Agreement as well as applicable regulatory requirements
• Coordinate and ensure Novartis Auditing is carried out including CAPA follow-up.
• Escalate any issues per the Novartis Escalation policy and initiate any market action that is required.
• Together with the ESO QA Head and Supplier Relationship Manager support to provide direction and formulate strategies to ensure efficient operation of External Supplier business as a whole.
• Participate in Projects as defined and ensure that all aspects are implemented and followed up

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:
• University degree in pharmacy, biochemistry, chemistry or comparable scientific studies
• Very good written and spoken English (fluent) as well as German language skills
• 5 years of experience in QA, QC, production, regulatory affairs and/or other GMP relevant areas in the pharmaceutical or medical device industry
• In-depth knowledge of GMP as well as proven experience with GMP inspections and solid understanding of regulatory guidelines for commercial drugs
• Very good knowledge of risk management and technical understanding of processes in the pharmaceutical industry
• Team oriented and experienced in dealing with complex issues and decisions

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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
Novartis Technical Operations
NTO QUALITY
Germany
Barleben
Quality
Full Time
Regular
No
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348035BR

Quality Assurance Manager ESO (f/m/d)

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