Position
The Senior Manager, Quality Assurance will have a strong focus on GMP, ensuring compliance with industry regulations while fostering a collaborative, cross-functional environment. Reporting to the Sr. Director, Quality Assurance this individual will play a critical role in developing and maintaining quality systems, driving excellence across all GMP activities.
About You
You are a GMP professional with expertise in the development and launch of GMP operational systems and processes. You appreciate rules that govern activities. You appreciate consistency.
What Youโll Do
- Assist with the development and implementation of GMP quality systems in accordance with ICH, FDA, EMA, global regulations and industry guidance.
- Review all documents/reports especially as they relate to method development, validation activities and other analytical activities.
- Provide compliance oversight for internal and contracted external GMP activities.
- Coordinate and/or perform virtual or on-site audits as needed.
- Provide quality oversight for GMP CDMOs (including quality agreements) and manage GMP product batch record review and disposition.
- Assist with the development, im...
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Eikon Therapeutics
Biopharmaceutical company using revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases.
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