Program Manager, Hims & Hers

• The ideal candidate will bring a strong background In project/program management within GMP-regulated environments and will serve as the Central point of coordination across engineering, quality, operations, and external vendors
• Bachelor’s degree in Engineering, Project Management, or a related technical discipline
• 5+ years of experience managing cross-functional projects or programs in GMP
• Pharmaceutical manufacturing (sterile and non-sterile)
• Proven success in managing capital projects, equipment installations, and product
• Launches within 503A/503B or CDMO environments
• Strong understanding of sterile compounding workflows, cleanroom classifications, and
• Aseptic processing best practices
• Working knowledge of USP 795, 797 & 800, cGMP, 21 CFR Part 210/211, and
• Validation lifecycle documentation
• Excellent organizational and problem-solving skills; ability to manage multiple
• Concurrent initiatives and conflicting priorities
• Proficiency in project management tools such as Smartsheet, MS Project etc. to produce
• Gantt charts and action trackers for concurrent projects
• Strong written and verbal communication skills; ability to influence cross-functional
• Teams and drive accountability
• Ability to gather and document requirements, track comments and get approvals from
• Different stakeholders to maintain accountability

Desirable

• We are seeking a proactive and detail-oriented Program Manager to help lead cross-Functional execution of sterile and non-sterile compounding initiatives within our 503A and 503B facilities.
• This role is critical in ensuring project delivery across capital buildouts, Equipment installs, tech transfers, and process improvements, all while maintaining Compliance and operational efficiency
• Program & Project Management
• Support and coordinate planning and execution of tasks within capital and operational
• Programs in sterile and non-sterile compounding environments, in partnership with the lead engineer
• Track integrated project plans, including timelines, milestones, risk mitigation actions, And deliverables
• Maintain up-to-date visibility into budgets, spend forecasts, change logs, and schedule
• Deviations; escalate concerns early
• Ensure timely follow-up and closure of assigned tasks across cross-functional teams
• Cross-Functional Execution
• Drive collaboration between engineering, validation, quality, pharmacy, and manufacturing teams to align resources and resolve blockers
• Facilitate weekly syncs, issue logs, and decision-making frameworks to ensure timely Project delivery
• Serve as liaison to external consultants, vendors, and contractors during equipment
• Selection, installation, and qualification
• Compliance & Documentation
• Ensure programs comply with cGMP, USP 795 & 797 & 800 and applicable FDA
• Track and manage change controls, deviations, and CAPAs related to capital projects
• And operational launches
• Support audit readiness by ensuring accurate documentation, traceability, and
• Resolution of program risks
• Facility & Equipment Enablement
• Oversee execution of cleanroom and process suite buildouts for sterile and non-sterile
• Compounding
• Coordinate readiness for equipment FATs, SATs, and site commissioning
• Partner with validation and engineering teams for timely completion of IQ/OQ/PQ
• Communication & Reporting
• Prepare and deliver concise program status reports to senior leadership
• Maintain dashboards, Gantt charts, risk registers, and other program governance tools
• Communicate across stakeholders with clarity and urgency to manage changing
• Priorities and constraints