Quality Systems Specialist

3 days ago


Cambridge, Massachusetts, United States Lifelancer Full time
Quality Systems Specialist: Lead Innovation in Pharmaceutical Industry

About the Company:
Lifelancer connects talented professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. Our platform helps companies find skilled candidates who can drive innovation and growth.

Job Summary:
The Quality Systems Specialist will lead the development of quality systems that support Akebia's commitment to delivering high-quality products. You will work closely with cross-functional teams to identify areas for improvement and implement changes that enhance our quality processes.

Key Responsibilities:
  • Develop and maintain quality agreements/technical agreements ensuring adherence to established expectations.
  • Plan and execute supplier audits including generating audit agendas and reports.
  • Collaborate with cross-functional teams to develop, implement, and maintain supplier quality management systems.
  • Provide technical and quality knowledge for supplier selection, qualification, audits, and approval, supporting proper selection of purchased products and suppliers for new products and life-cycle management of current products.

Requirements:
  • Bachelor's degree in a scientific discipline required, advanced degree preferred.
  • Minimum 6-8 years progressive responsibility in pharmaceutical/biotech GxP related quality environments.
  • In-depth knowledge of applicable cGMP/GCP/GLP/GVP regulations and guidelines.
  • Quality processes expertise related to operations and/or supplier quality.


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