ESO QA Compliance Oversight Manager (m/f/d)

Novartis Technical Operations
Division Novartis Technical Operations
Geschäftseinheit NTO QUALITY
Standort Holzkirchen (near Munich)
Funktionsbereich Quality
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 260490BR


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.

Sandoz is currently recruiting for an ESO QA Compliance Oversight Manager (m/f/d) to take care of the development, implementation and continuous improvement of NTO ESO QA processes, procedures and standards in compliance with cGMP/ICH, Regulatory Authority, and Novartis Group Quality Manual requirements and Policies.

Key Responsibilities

• Participation in the development, implementation and continuous improvement of NTO ESO QA processes, procedures and standards to ensure compliance with cGMP/ICH, Regulatory Authority, Novartis Quality Modules and Directives related to Supplier Management. Support the Development of ESO Quality management systems
• Create and/or review (as required) Standard Operating Procedures defining business processes for managing suppliers in the scope of ESO and monitoring performance against Novartis Quality Standards. Drive or support ESO procedures Governance and maintenance
• Drive and/or support the implementation of NTO ESO QA procedures or process acting as interface between Systems and Compliance and platforms/sites/entities managing supplies as an SME.
• Participate in ESO Quality-related initiatives as necessary or as requested by NTO or Group QA in order to provide SME inputs and support the roll-out to ESO QA and other platforms where suppliers are managed
• Drive improvement projects across ESO QA organization as needed
• Provide input or support the reporting on Global ESO Quality activities and Risk Assessments, and manage defined Key Quality Indicators (KQIs
• Support or manage the Track the KQIs vs. the targets established in the Quality Plan/target letter, aligned with NTO ESO QA strategy
• Interact with main stakeholders/ other functions / platforms/sites /entities to improve the quality and compliance for ESO Supplier Management
• Establish or support the maintenance and use of the communication channels (community calls, participation, when needed, on the High Risk meetings, sub-platform committees, etc.) with the other entities managing suppliers of finished products, bulk, packaging operations, API and intermediates (Country Organizations and sites, when applicable)
• Being externally engaged by maintaining current knowledge of local and international regulatory and legislative requirements and Trends
• Support any assigned specific ESO compliance activities as required (Compliance Oversight and/ or Quality Management System related related)



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:


• University degree or equivalent in Pharmacy, Chemistry, Biology or related subject
• A minimum of 5 years experience in the pharmaceutical industry in Quality- and Compliance-related activities or an equivalent of a strong proven background and knowledge in GMP operations (e.g. Manufacturing and Science)
• Supplier management oversight background desirable
• Extensivel knowledge in Quality Assurance/ Compliance and Auditing/ Project Management
• Thorough knowledge of cGMP requirements
• Collaborative team player
• Strong analytical skills and understanding of risk management fundamentals / tools
• Good interpersonal skills, including organisational,
analytical, intercultural communication and negotiation
• Decision-making ability and experience in an international matrix organization
• English fluent in speaking and writing, second language desirable



Why consider Novartis?
927 million. That’s how many lives our products touched in 2017. 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 are Sandoz. A Novartis Division. Join us and help us reimagine medicine.

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.

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.



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