Project Manager, Manufacturing Operations
Vital Bio
PMP
Senior Manager, QS Change Management
hims & hers
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $165,000 - $180,000 per year
Job Level
Senior
Tech Stack
PMP
About the role
- Own the change management program globally, leading its design, rollout, and continuous improvement across multiple sites.
- 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.
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.
- 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.
