Sr. Manager, QS Change Management
Hims & HersAbout the role
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 and 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.
About the Role:
We are seeking a highly experienced and motivated Quality Systems Senior Manager with a strong emphasis on change management and enterprise quality leadership to join our Global Quality Systems team. This role will be instrumental in creating, operationalizing, and maintaining a best-in-class quality system across the Hims & Hers network.
The Sr. Manager will own the change management program globally, leading its design, rollout, and continuous improvement across multiple sites. This individual will not only manage the processes but also serve as a strategic partner to leadership, ensuring compliance, product quality, and business continuity while driving a culture of quality excellence.
This position is remote, with travel required to sites to support implementation and sustainment of quality processes.
You Will:
Change Management Leadership
Serve as the global owner and subject matter expert (SME) for the end-to-end change control process within the Quality Management System (QMS).
Design, implement, and continuously enhance robust change management procedures aligned with regulatory requirements (FDA, EMA, USP, ISO, ICH).
Lead and facilitate Change Review Boards (CRB) at the enterprise and site levels, ensuring timely, risk-based decision-making.
Partner cross-functionally with R&D, Operations, Legal, Site Quality, and Supply Chain to ensure seamless integration of changes into operations.
Assess the impact of changes on product quality, compliance, and business continuity, mitigating risks proactively.
Develop and deliver enterprise-wide training on change management best practices and related quality system topics.
Quality Systems Leadership
Provide strategic oversight and leadership in designing, implementing, and sustaining key quality systems (CAPA, deviations, audits, document control, training, etc.).
Lead quality improvement initiatives focused on system optimization, risk mitigation, and digital transformation of QMS tools.
Represent Quality Systems in executive governance forums and external regulatory inspections.
Establish global quality metrics and KPIs; monitor performance and implement strategies for continuous improvement.
Act as a mentor and coach, building a high-performing quality systems team and embedding a culture of accountability and compliance.
You Have:
Bachelor’s degree in life sciences, engineering, or related field; Master’s degree preferred.
8–10+ years of progressive experience in quality systems within regulated industries (pharmaceutical, biotech, medical device).
4–5+ years of leadership experience managing cross-functional or global quality initiatives.
Deep expertise in change management frameworks and enterprise QMS deployment.
Proven success in regulatory inspections (FDA, EMA, ISO) and inspection readiness activities.
Strong knowledge of global GxP requirements (21 CFR Part 11, USP, ISO 13485, ICH Q10, etc.).
Excellent project management and organizational skills with the ability to lead multiple, complex programs simultaneously.
Strong executiv
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