Hims & Hers
Healthcare
SeniorManager,QualitySystems
Neural analysis suggests this role is
optimal for Manager candidates.
“Senior Manager, Quality Systems at Hims & Hers. Skills: Quality Management System, CGMP manufacturing, Data Integrity. Lead QMS design. Implement QMS improvements”
Industry & Context.
Root cause analysis
What They're Looking For.
Must Have
Bachelor's degree in Life Sciences, 7+ years of progressive experience
What You'll Do.
Implement QMS improvements
Administer electronic QMS
Develop quality metrics
Report quality metrics
Ensure record compliance
Champion data integrity
Own Deviation programs
Coach Deviation owners
Approve Deviation records
Own Change Control program
Drive risk-based guidance
Establish governance processes
Develop training program
Implement training program
Maintain training program
Conduct training assessments
Develop training materials
Establish internal audit
Support FDA inspections
Support state board inspections
Support global inspections
Author responses to observations
Drive corrective actions
Partner with Manufacturing
Partner with Engineering
Partner with Regulatory
Partner with site leadership
Resolve quality issues
Maintain regulatory expertise
Implement regulatory changes
How You'll Work.
Team & Collaboration
Cross-functional teams; Site leadership; Global process owners
Process & Methodology
Risk-based guidance
Full Job Description
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about http://hims.com/about and hims.com/how-it-works http://hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals. ABOUT THE ROLE: The Sr. Manager, Quality Systems serves as the subject matter expert (SME) and owner of the site Quality Management System (QMS) within a sterile cGMP manufacturing environment. This role is responsible for designing, establishing, maintaining, and continuously improving the QMS framework — including Document Control and Data Integrity, Change Control, Deviations and CAPA, Training, Internal Audit, and Management Review — in alignment with FDA cGMP (21 CFR 210/211/11), Section 503B, and other applicable standards. The successful candidate will bring deep Quality Systems expertise, a builder’s mindset, and a proven track record of strengthening compliant, audit-ready systems in sterile pharmaceutical operations. This individual will be central to ensuring inspection readiness, regulatory compliance, and a culture of continuous improvement across the site. This role will begin as an individual contributor and site SME for Quality Systems, with the opportunity to build and lead a tea
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