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QA Team Leader, QMS

Glenmark Pharmaceuticals S.A.

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Glenmark Pharmaceuticals (www.glenmarkpharma.com) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology.


Glenmark’s biologics research operations in Switzerland focuses on the discovery and development of new biological entities from inception through preclinical and clinical studies. With a world-class, GMP-certified manufacturing line, our Swiss site located in the canton of Neuchâtel is well-positioned to fully serve the company’s growth in biologics research and development. The facility provides Glenmark with a complete suite of end-to-end, in-house capabilities necessary for early production of investigational biologics medicines, including cell line development, bioassay development and antibody engineering, as well as upstream and downstream development


Glenmark is a rapidly growing company with many exciting and challenging career opportunities. We continue to recruit talented professionals who would like to contribute to our success and who share our values of respect, knowledge and achievement.

QA Team Leader, QMS

Glenmark Pharmaceuticals (www.glenmarkpharma.com) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology.


Glenmark’s biologics research operations in Switzerland focuses on the discovery and development of new biological entities from inception through preclinical and clinical studies. With a world-class, GMP-certified manufacturing line, our Swiss site located in the canton of Neuchâtel is well-positioned to fully serve the company’s growth in biologics research and development. The facility provides Glenmark with a complete suite of end-to-end, in-house capabilities necessary for early production of investigational biologics medicines, including cell line development, bioassay development and antibody engineering, as well as upstream and downstream development


Glenmark is a rapidly growing company with many exciting and challenging career opportunities. We continue to recruit talented professionals who would like to contribute to our success and who share our values of respect, knowledge and achievement.

RESPONSIBILITIES:


  • Lead a team of Quality professionals responsible for Biological GMP Quality compliance.

  • Ensure effective Quality oversight over biologics development and clinical manufacturing.

  • Drive and monitor the implementation of a commercial biological quality system in Switzerland and support the setup of commercial facility.

  • Maintain and improve the company Quality Management System (QMS) in compliance to PIC/s, EMA and FDA requirements.

  • Pro-actively identify, develop and implement quality improvements in response to business requirements, technical changes and regulatory requirements.

  • Manage, mentor and develop direct reports within Quality group

  • Plan and prepare quality resourcing and budgets.

  • Assist the Qualified Person for maintaining and improving batch release process and support for the facility and its utilities 

REQUIREMENTS:


  • Master of Science degree in Pharmaceurical sciences, biochemistry or related discipline or equivalent, with at least 8 years’ experience in GMP with at least 4 years’ experience in a line management or decision making quality role.

  • Solid understanding of quality management systems and continues process improvement principles including global cGMP requirement, and other relevant regulations and guidance to assure quality products.

  • Highly organized with strong verbal and written communication skills

  • Fluent English is required, French is highly desirable.

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