Full-Time

Senior Manager

Quality Systems Change Management

Posted on 8/27/2025

hims & hers

hims & hers

1,001-5,000 employees

Telehealth platform for personalized medical treatments

Compensation Overview

$165k - $180k/yr

Remote in USA

Remote

Category
Medical, Clinical & Veterinary (1)
Required Skills
Risk Management
Requirements
  • 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 executive presence with the ability to influence senior stakeholders and decision-makers.
  • Track record of mentoring, coaching, and building high-performing teams.
Responsibilities
  • 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.
  • 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.
Desired Qualifications
  • Professional certifications such as ASQ CQE, CQA, PMP, or Lean Six Sigma Black Belt preferred
  • Experience with quality systems software platforms (Veeva, MasterControl, TrackWise) preferred
  • Demonstrated ability to scale QMS processes in high-growth or multi-site organizations.

Hims & Hers is recognized for blending telehealth convenience with a wide range of personalized medical services, from sexual health to mental health. The employment environment is backed by a commitment to technical excellence and a progressive approach to healthcare, offering opportunities to work on cutting-edge treatments that address diverse patient needs. Its culture promotes innovation and patient-centric solutions, providing a motivating workspace for professionals looking to impact healthcare accessibility and quality.

Company Size

1,001-5,000

Company Stage

Post IPO Equity

Headquarters

San Francisco, California

Founded

2017

Benefits

Full healthcare - High-coverage medical, dental & vision coverage for individuals and families

Generous PTO

Retirement planning - Take advantage of our 401(k) plan including contribution matching

WFH stipend

Robust compensation

Employee discount

Utility stipend - An extra $75 each month to cover extra cell phone, internet, or data usage

Spending accounts - Options for additional HSA and FSA plans to help toward healthcare costs

Growth & Insights

Headcount

6 month growth

1%

1 year growth

1%

2 year growth

1%
INACTIVE