Quality Management System Lead
$151,200–$226,800 year
On-siteBoston, Massachusetts, United States
Job Summary
Own and continuously improve the QMS framework to ensure processes, document control, training, and quality records support consistent compliance across functions and regions. Define and maintain QMS structure including policies, SOPs, work instructions, templates, and governance while ensuring harmonization across GxP domains and alignment with applicable regulations. Oversee document lifecycle management, change control processes, and the GxP training framework from curricula to compliance reporting. Ensure QMS records are complete, traceable, audit-ready, and meet data integrity principles while establishing metrics for QMS health. Lead QMS simplification and CAPA prevention initiatives based on trending and learnings. Prepare Quality Management Review packages containing KPIs, risks, audit outcomes, and improvement plans.
Required Qualifications
- Bachelor's degree in Life Sciences, Quality, or related discipline
- 8–12 years in Quality Assurance or Compliance
- Hands-on experience managing QMS in regulated GxP environments
- Experience supporting QMS-related inspections and audits
- QMS design, lifecycle management, and governance
- GxP training systems and compliance tracking
- Data integrity and document control standards
- Process‐oriented, structured, and detail focused
- Strong communication and training skills
- Ability to simplify complex processes and drive alignment
Desired Qualifications
- Quality-related certification preferred (e.g., ASQ, ISO Lead Auditor, Quality Systems)
- Training in electronic QMS platforms advantageous
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