Pharmaceutical Quality Manager

1 month ago


Cambridgeshire and Peterborough, United Kingdom Clinical Professionals Limited Full time

**Job Title:** Pharmaceutical Quality Manager

Location: Cambridge

Clinical Professionals Limited is a leading provider of pharmaceutical and medical device development services. We are currently seeking a highly skilled Pharmaceutical Quality Manager to join our team in Cambridge.

About the Company:

  • Clinical Professionals Limited is a renowned expert in the field of pharmaceutical and medical device development.

Key Responsibilities:

  • Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
  • Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
  • Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.

Requirements:

  • BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries
  • OR MSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries
  • OR PhD in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline)
  • History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation
  • Understand Good Manufacturing Practices (GMP)


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