Senior Quality Assurance Auditor

2 weeks ago


Manchester, United Kingdom Lonza Full time

About the Role:

The Quality Management System is the global process owner of Lonza’s core Quality processes. In this position, you will build and continuously improve efficient and effective global Quality processes in close collaboration with the Lonza network, meeting business needs and aligning with regulatory requirements and industry best practices.

Key Responsibilities:

  1. Responsible for the life cycle management of the owned global GxP Quality processes, as well as building and leading a global network of subject matter experts to promote best practice sharing and continuous improvement.
  2. Drive continuous improvement of core Quality processes, including the development of effective training packages and delivering training required for the global implementation of those processes.
  3. Process owner of the Trackwise system, including assuring access management concepts, maintenance of the validated state, and chairing the Trackwise change review board.
  4. Support the sites in the implementation and standardization of the global Quality processes and procedures.
  5. Support regulatory inspections and customer audits for the owned global Quality processes.
  6. Engage strong cross-functional relationships to drive global quality system improvements, including chairing Community of Practice meetings (Deviation, CAPA, Change Control).
  7. Bachelor/Master Degree in Biochemistry, Biology, Chemistry, Pharmacy, or equivalent.
  8. Proven hands-on experience in the development, implementation, maintenance, and governance of modern corporate Quality Systems and electronic tools in the pharma-biotech industry.
  9. Broad work experience in QA and in-depth knowledge of Quality Systems across different GxP areas and global health authority regulations (drug substance, drug product, medical device, excipients, nutritional products, including in-depth knowledge of FDA/EU regulations).
  10. Excellent knowledge of computer systems with demonstrated skills in the use of information management systems in a GxP environment (eQMS (Trackwise/Veeva) or eDMS (Documentum/Veeva), training (Cornerstone), etc.).
  11. Operations or laboratory experience in chemical and biological GMP manufacturing (drug substance, drug product, etc.) is a plus.
  12. Excellent English skills, both written and spoken; knowledge of additional languages is an advantage.


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