ESO Senior QA Manager Biotechnology and Aseptics (m/f), Schaftenau, AT
- Kufstein, Austria
Sourcing Statement You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.
25! This is the number of Novartis production sites that our Austrian External Supplier Organization (ESO) Team supports all over the globe. Being part of the ESO team you will be working in a very international team with a lot of global interaction and attractive tasks.
Your responsibilities include, but are not limited to:
• Provide direction and formulate strategies to maintain and improve the external supplier quality oversight
• Act as single point of contact for all quality related activities at the external supplier
• Lead the external supplier qualification process, including setup and maintenance of related core documents (e.g. quality assurance agreement, supplier quality risk assessment)
• Manage all quality aspects of the relationship in accordance with the effective Quality Agreement, the Novartis Quality Manual, relevant cGMP regulatory requirements and local SOPs. Including but not limited to the management of investigations (complaints, deviations, out of specification results, quality events), change controls, and regular quality reviews (e.g. annual product review)
• Oversee the technical release of batches manufactured at the CMO. Including but not limited to batch record review, incident review, and change review
• Escalate any incident per Novartis escalation policy, and initiate any market action that is required
What you'll bring to the role:
• Bachelor or higher in Biochemistry, Chemistry, Microbiology or other related science
• Fluent in speaking/writing English
• Minimum 8 years of experience in in the pharmaceutical industry
• Minimum 5 years of experience in the manufacturing of sterile pharmaceuticals. Expert knowledge in aseptic/sterile pharmaceutical processes
• Minimum 3 years of experience in manufacturing of biologic medicinal products
• Minimum 5 years of experience in operational quality assurance. Expert knowledge of cGMP requirements for major regulated markets (EU, US)
• Proven track record with FDA, EMEA and other Health Authorities
• Experience in managing third party manufacturer is a plus.
• Team and consensus builder with strong negotiation skills and decision-making ability. Strong communication and leadership skills
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, 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?
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 opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 62146,14 EUR per year on a full time basis).
Imagine what you could do at Novartis!
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Commitment to Diversity & Inclusion:
Novartis 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.
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
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