ESO QA Manager (m/f) Business Development & Licensing

Novartis Technical Operations
Division Novartis Technical Operations
Geschäftseinheit NTO QUALITY
Standort Holzkirchen (near Munich)
Funktionsbereich Quality
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 249255BR


Stellenbeschreibung

Job Summary

Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives?

Look no further, apply today. ESO QA Manager (m/f) Business Development & Licensing, Sandoz, Holzkirchen (near Munich), Germany.

Job purpose

Sandoz is currently recruiting for a ESO QA Manager (m/f) Business Development & Licensing to support the ESO BD&L, Transfer and Launch platform in the delivery and coordination of QA risk assessments to the different governance bodies and to provide quality management oversight on global, regional and local Business Development and Licensing (BD&L) arrangements.

Key Responsibilities

• Primary decision maker for QA GMP oversight of BD&L arrangements and transfers and key point of contact for cross regional deals (Global)
• Responsible for proactive policy setting and Quality evaluation - this includes development, implementation and continuous improvement of globally standardized data, processes, procedures and standards
• Facilitate the global Quality decision making process for Global, Regional and Local BD&L arrangements in the high level reviews at the partner selection board and the in depth evaluation for the supply point committee (SPC)
• Establish and maintain Liaison with key stakeholders: Global BD&L (and Country management), Regional/Local QA, LRC, MS&T, SPC. Engagement with Sandoz and Pharma Development on supplier selection
• Ensure that potential compliance gaps and risks in relation to BD&L arrangements are identified and flagged early and continuous improvement is implemented
• Work closely with Sandoz stakeholders to ensure development of robust processes in order that key ESO launches are not jeopardised due to poor quality oversight or lack of proactive Quality management. Timely input to the Sandoz Global Launch Review board on a monthly basis.



Quality


Mindestanforderungen

About Sandoz

Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached well over 500 million patients. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

Benefits of Working for Sandoz

• Competitive salary
• Performance based annual bonus
• Work/life integration
• Eligible to Sandoz pension plan
• 30 working days' holiday per calendar year
• Subsidised on-site cafeteria
• Free shuttle bus between Sandoz and Holzkirchen train station
• Additional benefits

‘I came for the job, I stay for the culture’


The ideal candidate will have

• Degree or PhD in Life Sciences, Pharmacy or Medicines
• At least 10 years’ experience in the pharmaceutical industry, including operative experience in QA and/or Production/Technical Operations, with at least 5 years in Quality (Assurance) and involvement in regulated activities
• Extensive GxP experience (based on different roles in Quality Assurance)
• Broad understanding of global expectations of health authorities in GxP regulated areas
• 5 or more years of demonstrated leadership and accomplishments in an international matrix organization i.e. successfully leading an organization or project of high impact
• English fluent in speaking and writing, second language desirable



We focus on creating an inclusive organisation and welcome people who have different knowledge, perspectives, experience and working styles from across the global population.



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