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Senior QA Lead, External CMOs - GMP Compliance

Initial Therapeutics, Inc.

Initial Therapeutics, Inc. is hiring for a QA management role focusing on ensuring compliance within contract manufacturing operations. The role involves oversight of Quality Management Systems, partnering with quality leaders, and supporting validation efforts for drug products. Ideal candidates will have over 7 years in the pharmaceutical sector, understanding regulatory compliance, and are expected to frequently collaborate across functional teams. The position includes travel requirements of up to 30% and offers a competitive salary range. #J-18808-Ljbffr Initial Therapeutics, Inc.

Vacancy posted 3 days ago
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