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Quality Control Manager, Sterile
Hims & HersTelemedicine company
Gilbert, United StatesManager
Thrive Capital
Forerunner Ventures
8VC
Operations & Strategy
About the role
TL;DR
Oversee QC activities to ensure sterile drug products meet quality and regulatory standards.
- •The Quality Control (QC) Manager is responsible for overseeing and executing all QC shop floor activities to ensure compounded sterile preparations (CSPs) meet established quality, safety, and regulatory standards.
- •Key Responsibilities Oversee sampling, testing, and documentation of sterile drug products for sterility, endotoxin, potency, identity, particulate matter, and pH, as applicable.
- •Manage coordination with third-party analytical laboratories, including sample submission, data review, and investigation of test abnormalities.
- •Review and approve Certificates of Analysis (COAs) and ensure results meet specifications prior to product release.
- •Manage quality control shop floor activities during compounding operations to ensure appropriate coverage over all shifts.
- •Collaborate with Microbiology and Pharmacist in Charge on investigations for out-of-specification (OOS) results, sterility failures, and environmental excursions.
- •Requirements Bachelor's Degree in a related field (e.g., Pharmacy, Microbiology, Chemistry) required; advanced degree preferred.
- •Extensive experience in a sterile compounding environment, preferably in a 503A facility.
- •Strong understanding of USP , USP , USP , and FDA guidance applicable to sterile compounding.
- •Proven leadership experience with a track record of managing quality control teams.
- •Excellent problem-solving skills and the ability to implement corrective and preventive actions (CAPA).
Required skills
Compliance Management
Domain expertise
healthcare