ESO QA Lead (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 255569BR


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 Lead (m/f/d), Sandoz, Holzkirchen (near Munich), Germany.

Sandoz is currently recruiting for an ESO QA Lead (m/f/d) to provide leadership and manage Quality Assurance Managers.


Job purpose

The purpose of this QA Lead role is to provide leadership and manage Quality Assurance Managers for ESO QA (co-located and/or remote) in all quality-related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements and the Novartis Quality Manual and Policies.

• Ensure that all aspects of the manufacturing of products for Novartis at identified CMOs and Suppliers located in area of responsibility comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP, regulatory and legislative requirements.
• Provide leadership, direction and support to third parties (both local and global sup-pliers) and ensure that they are qualified, achieve a high level of competence and are motivated to carry out their duties in a safe manner. This includes regular site visits to local suppliers.
• Responsible for driving/initiating External Supplier Quality Risk assessments in conjunction with the QAM for all External Suppliers within the responsibility of the team.
• Lead site readiness for regulatory inspections at external suppliers where appropriate.
• Review all critical quality issues in conjunction with the QAM according to the Quality Assurance Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed.
• Responsible for assessing Quality trends and leading continuous improvement for processes and product quality performance across external suppliers.
• Escalate all potential quality issues as per the Novartis escalation policy and to higher level management

Within the organization
• Provide leadership, direction and support to direct reports and grow talent
• Provide quality presence and input to technical meetings with the external suppliers and establish good working relationships with clear communication and defined actions and goals. In addition, provide support to internal functions by evaluation and decision of new products as per Novartis Quality Manual and standards.
• Perform required periodic review and make recommendations for amendments to the evaluation based on identified needs and issues. Maintain coordinated contact with other functions.
• Ensure that coordinated contact is maintained with the Regulatory Authorities, the lo-al partners (suppliers, third parties) and Global Quality Operations (ESO QA).
• Together with the Supplier Relationship Manager participate in providing direction, formulate strategies and make decisions which ensure an efficient operation of the External Supplier business as a whole. Participation in the Business review of external suppliers.
• Ensure KPIs are met and reported monthly by the team.
• Participate in the ESO Quality Plan - ensure that all quality issues at external suppliers are included


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’



Quality


Mindestanforderungen

The ideal candidate will have

• Higher university degree (e.g. MS or Ph.D.) in Biochemistry, Chemistry, microbiology or another related science
• At least 10 years of working experience in a GMP environment in a quality function
• Ideally brings along knowledge in microbiology and chemistry related to sterile processes and in equipment/plant set-ups
• Strong leadership skills and experience with managing direct reports
• Strong communication and collaboration skills
• Flexible and goal-oriented
• Fluent in English, another language like e.g. German is beneficial


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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