NL - Specialist 3, Quality Assurance

Job Description:

Janssen Supply Group is recruiting for a support associate located in remotely and working for External Quality, Leiden, The Netherlands.

In this position you will be responsible for providing support to the account manager Qualified Person through review of batch and validation documentation, completion of release packages, and management of routine issues to ensure the highest levels of quality and compliance for Janssen Biologics products.

The position requires demonstrated 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.

This position requires travel and can be performed remotely.

Key Responsibilities:

• 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 minor issues.

• Consult with 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 external manufacturing sites are executed in a compliant manner.

• Proactively identify risks and potential issues and delays in market release, and where possible, drive resolution. 

• Extensive (> 3 y) knowledge of GMP, specifically parenteral experience is preferred (QA and/or production).

• Able to connect easily, team worker, able to manage across cultures.

• English mandatory, other languages are a benefit.

Experience and Skills:

• Middle to Higher education.A

• minimum of 8 years working in an FDA or similar regulated environment; Quality Assurance experience preferred

• A minimum of 5 years experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production)

• Able to build connections with stakeholders, and manage across cultures

• Strong interpersonal and written/oral communication skills

• Proficient in applying process excellence tools and methodologies

• Amount of travel 25%

• English mandatory, other languages are a benefit

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.