SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Hims & Hers, a leading public health and wellness platform (NYSE: HIMS), is seeking an experienced Quality Control Manager for Sterile Compounding to join the Quality Unit at its large-scale compounding pharmacy in New Albany, Ohio. Reporting to the Director of Quality, you will lead quality control operations for sterile pharmaceutical compounding, overseeing in-process and final product inspections while ensuring compliance with USP <795, 797, 800> standards, cGMP practices, and FDA regulations.
Key responsibilities include: leading and performing in-process and post-production quality checks including product inspection and testing at various compounding stages; managing day-to-day production floor activities to ensure product and raw material compliance; compiling, analyzing, and presenting trending data and quality reports to QA management; overseeing investigations into non-conformances, deviations, and customer complaints with root cause analysis and corrective actions; managing the product retention program; collaborating with production and pharmacy teams on quality improvement initiatives; maintaining oversight of critical equipment verifications and calibrations; reviewing and approving compound records, Certificates of Analysis, and raw material documentation; drafting and implementing SOPs and protocols aligned with USP and regulatory requirements; ensuring ongoing compliance with sterile and non-sterile compounding guidelines; supporting internal and external audits and inspections; managing relationships with contract laboratories; and training and mentoring pharmacy and production staff on quality standards.
Required qualifications: 3+ years of quality control or quality assurance experience in sterile compounding or pharmaceutical manufacturing; strong experience with environmental monitoring and sterile floor environments; strong working knowledge of USP <795, 797, 800> and cGMP standards; experience in regulated environments (FDA 21 CFR 210/211 preferred); proven leadership and coaching skills; exceptional communication abilities; proficiency with Microsoft Office Suite and MRP systems (preferred); ability to manage multiple priorities with high attention to detail; strong technical writing skills; familiarity with quality metrics, root cause analysis, and statistical quality control methods; and proven ability to build cross-functional partnerships. Bachelor's degree in Chemistry, Biology, Pharmacy, Quality Management, Engineering, or related field is preferred. Pharmacy Technician license required or must be obtained within first six months (company covers costs and provides support).
Nice-to-have qualifications include experience in 503A or 503B compounding facilities, management of environmental monitoring or contamination control programs, and experience supporting facility expansions, FDA inspections, or operational scale-up projects.
The role requires working with hazardous drugs and wearing appropriate PPE (gloves, respiratory protection, gown) and medical approval to wear respiratory protection devices.
