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Senior Quality Assurance Director

2 months ago

California, United States SciPro Full time

Associate Director Quality Assurance (Good Laboratory Practice - GLP)

SciPro is collaborating with a rapidly expanding Biotechnology firm located on the West Coast, boasting a diverse product range and pipelines across various Therapeutic Areas. This organization is currently in search of a seasoned GLP Quality Specialist to join their team as an Associate Director for Quality Assurance.

Key Responsibilities

  • This role involves direct engagement with business operations, providing GLP-centric Quality consultation across Research & Development divisions.
  • You will collaborate with external partners and laboratories to guarantee adherence to GLP standards, both internally and in accordance with domestic and international regulations.
  • Your responsibilities will also include formulating Quality strategies with an emphasis on GLP, alongside the development of Quality metrics and KPIs, which will be presented to Senior Leadership.

Qualifications

  • Significant experience in GLP Quality Assurance within the Pharmaceutical, Biotechnology, or Medical Devices sectors.
  • Proven track record in managing External Vendors, both within the country and internationally.
  • Expertise in the creation and oversight of 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 position offers a unique opportunity to contribute to a dynamic organization at the forefront of Biotechnology.