Senior Manager, Quality Systems

Responsibilities

• Lead the design, implementation, and continuous improvement of the site Quality Management System (QMS) in compliance with cGMP and 503B standards.
• Implement and administer the site electronic QMS (TrackWise), including data migration and process development.
• Own the Deviation and CAPA programs, ensuring sound root cause analysis and effective closure.
• Manage the Change Control program, providing risk-based guidance across cross-functional teams.
• Oversee the document control system for all GMP documentation, ensuring data integrity (ALCOA+) and compliance with 21 CFR Part 11.
• Develop and maintain the site training/competency program and Learning Management System (LMS).
• Establish and lead the internal audit program to maintain continuous inspection readiness.
• Support FDA, state board, and global audits, including authoring responses to observations.
• Develop and report quality metrics and KPIs to site and senior leadership to drive data-driven decision-making.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Quality, or a related field.
• 7+ years of progressive Quality Assurance/Quality Systems experience in an FDA-regulated environment.
• Direct experience with sterile injectable cGMP or 503B manufacturing.
• Demonstrated ownership of QMS elements including document control, change control, deviations, CAPA, training, and audit.
• Hands-on experience implementing and administering an eQMS (e.g., TrackWise).
• Deep working knowledge of industry regulations including FDA, ISO, ICH, and EMA.
• Proven experience supporting regulatory inspections and audits.
• Strong background in root cause analysis and risk management.

Preferred Qualifications

• Experience building or remediating quality systems in a high-growth environment.
• Experience leading, mentoring, or developing teams.
• Ability to interface effectively with Senior Leadership regarding metrics and remediation plans.

Benefits

• Competitive salary and equity compensation.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits including medical, dental, vision, and parental leave.
• Employee Stock Purchase Program (ESPP).
• 401k with employer matching contribution.
• Offsite team retreats.

About the Company

Hims & Hers is a leading health and wellness platform on a mission to help the world feel great through better health. We are redefining healthcare by delivering affordable, accessible, and personalized care from diagnosis to delivery.