Vacature Manager External Quality

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Manager External Quality, Large Molecule EMEA

• Job Title Manager External Quality, Large Molecule EMEA
• Function Quality
• Sub Function Quality Assurance
• Location Leiden, South Holland, Netherlands
• Date Posted Nov 30 2023
• Requisition Number 23W

Description

Work at Janssen Supply Group as a support manager for External Quality at the FDBD site.

Responsible for providing support to the account manager through review of batch and validation documentation, assessment of deviation investigation, CAPAs and change requests, completion of release packages and management of routine issues to ensure the highest levels of quality and compliance for Janssen Biologics products.

Specific Objectives:-

• Interact with Internal Quality Assurance Managers and External Manufactures to perform batch record review and complete release packages for global markets.
• Evaluate batch manufacturing records, deviations and associated CAPA plans, and identify issues which may impact the quality of the product or the compliance to marketing authorizations.
• Independently resolve issues.
• Consult and inform the account manager as needed for resolution of major issues
• Ensure that all relevant QA related concerns at external manufacturing sites are raised to Janssen management.
• Ensure Janssen specific manufacturing operations at external manufacturing sites are executed in a compliant manner
• Proactively identify risks and potential issues and delays in market release, and where possible, drive resoluti
• Individually support PPQ at the site

· Knowledge of the requirements for the production and release of Biologics products in the EU and associated countries, and in-depth knowledge of deviation management processes.

· A minimum of 5 years working in an FDA or similar regulated environment; Quality Assurance experience preferred.

· A minimum of 3 years experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production).

· Strong interpersonal and written/oral communication skills.

· Proficient in applying process excellence tools and methodologies.

Effective Date

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Qualifications

• Knowledge of the requirements for the production and release of Biologics products in the EU and associated countries, and in-depth knowledge of deviation management processes
  
• A minimum of 5 years working in an FDA or similar regulated environment; Quality Assurance experience preferred.
  
• A minimum of 3 years experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production)
  
• Strong interpersonal and written/oral communication skills
  
• Proficient in applying process excellence tools and methodologies
  
• English mandatory, other languages are a benefit.
  The employers of the Johnson & Johnson family value diversity and inclusion. We are committed to building diverse teams that reflect both the patients and the partners we support. We strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential.

We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.

Functie:	external quality manager
Startdatum:	06-12-2023
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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