Senior GLP Quality Assurance Manager

1 week ago


California, United States SciPro Full time

Director of Quality Assurance - Good Laboratory Practice (GLP)

SciPro is collaborating with a rapidly expanding Biotechnology firm on the West Coast, boasting a diverse product portfolio and pipelines across various Therapeutic Areas. This organization is currently seeking a seasoned GLP Quality Specialist to take on the role of Director of Quality Assurance.

Key Responsibilities

  • This position involves direct engagement with business operations, providing GLP-oriented Quality guidance across Research & Development teams.
  • You will collaborate with external partners and laboratories to ensure adherence to GLP standards in alignment with internal, national, and international regulations.
  • Your role will also include formulating Quality strategies centered on GLP, as well as establishing Quality metrics and KPIs to be communicated to Senior Leadership.

Qualifications

  • Significant experience in GLP Quality Assurance within the Pharmaceutical, Biotechnology, or Medical Device sectors.
  • Proven track record in managing External Vendors on both domestic and international fronts.
  • Expertise in developing and overseeing Standard Operating Procedures (SOPs), conducting Internal & External Audits, and managing Corrective and Preventive Actions (CAPAs) and Deviations.
  • A minimum of a Bachelor's degree in Life Sciences or a related field.

This role presents an exciting opportunity for professionals looking to advance their careers in Quality Assurance within a dynamic and innovative environment.



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