Johnson & Johnson Careers
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Senior Manager QA NPI & Combo Products
Requisition ID: 1805647791W
Objectives and Responsibilities:
- Lead the QA NPI group within the Pharma Quality Assurance
- Support Pharma Operations, PDMS and Quality Assurance in order to insure full compliance with current FDA and EMEA regulations
- During NPI & TT ensure that business needs and quality systems are aligned
- Develop a culture of continuous improvement to ensure compliance with regulatory requirements and expectations
- Provide input to establish effective systems, measurements and trackings for the monitoring and control of pharmaceutical manufacturing
- To act as a site Quality representative in NPI & TT projects, starting from receive of the Drug Substance / API until Drug Product, e.g.
- To coordinate timely input from all relevant Quality departments and to ensure that all quality related activities with regards to projects are implemented in a compliant way and within the project timelines.
- To assure that all products manufactured meet the requirements according to current guidelines.
- to support, as required, technical and quality improvements with suppliers
- to support, as required, technical and quality improvements with other JSC subsidiaries or business partners
- To alert the Project Manager(s) and Head of QA Pharma of any quality issues which may impact on the compliance status of the project(s) or negatively impact the project timelines
- to leverage with other organisations within J&J to ensure that the best technical and compliance solutions are realized
- 5-10 years experience in manufacturing, preferably in Quality Assurance
- Previous people leadership experience
- Experience working in matrix organization
- Technical or Science degree
- Past responsibility for multiple projects
- Advanced communication skills
- Advanced level of English language, German knowledge would be an asset
If you are interested in this role please send us your online application (CV, Motivation Letter, Working References etc.)
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