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Contract Biologics Specialist

1 month ago

London, Greater London, United Kingdom Mantell Associates Full time

Mantell Associates is partnering with a Pharmaceutical organisation to find a Contract Qualified Person focused on Biologics to join their release team and build a quality strategy.

Key Responsibilities:

  • Act as Qualified Person for commercial products
  • Responsible for all aspects of release relating to the Quality organisation, including Quality Assurance (QA), Quality Control (QC) and Quality Management System (QMS)
  • Provide leadership and strategy to ensure that all products/services and releases are aligned with quality standards, regulations and customer/regulatory requirements
  • Work closely with the senior Operations team to transform and create a culture of compliance excellence
  • Onsite and Virtual Release
  • Work closely with the Manufacturing, Regulatory Affairs and other departments to make suggestions, set objectives and execute solutions for improvements in processes and compliance

Requirements:

  • Bachelor's degree or higher in a scientific area
  • Previously registered as a QP
  • Experience in Biologics
  • Proven experience in management and leading Quality in a technical manufacturing environment
  • Proven experience controlling Quality Management Systems (QMS) and with Good Manufacturing Practices (cGMPs)
  • Must possess strong written and oral communication skills, ability to influence change/be a change agent, and be able to coach, mentor and train others
  • Excellent knowledge and previous collaboration with regulatory guidelines
  • Strong working knowledge of GxP and quality systems

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm.