Quality Systems Specialist
3 days ago
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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