Quality Management System Lead
About The Position
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: policies, SOPs, work instructions, templates, and governance. Ensure harmonization across GxP domains (GMP/GLP/GCP) and alignment with applicable regulations/standards. Oversee document lifecycle management (authoring standards, review/approval, periodic review, archival). Ensure change control processes exist and are followed (QMS changes and cross-functional change impacts). Oversee GxP training framework (curricula, assignment rules, effectiveness checks, compliance reporting). Partner with functional owners to define role-based training requirements. Ensure QMS records are complete, traceable, audit-ready, and meet data integrity principles. Establish metrics and trending for QMS health (cycle time, overdue items, training compliance). Lead QMS simplification/optimization, including CAPA prevention initiatives based on trending and learnings. Prepare Quality Management Review packages: KPIs, risks, audit outcomes, CAPA effectiveness, and improvement plans.
Requirements
- Bachelor’s degree in Life Sciences, Quality, or related discipline (required)
- 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
Nice To Haves
- Quality-related certification preferred (e.g., ASQ, ISO Lead Auditor, Quality Systems)
- Training in electronic QMS platforms advantageous
Responsibilities
- Define and maintain QMS structure: policies, SOPs, work instructions, templates, and governance
- Ensure harmonization across GxP domains (GMP/GLP/GCP) and alignment with applicable regulations/standards
- Oversee document lifecycle management (authoring standards, review/approval, periodic review, archival)
- Ensure change control processes exist and are followed (QMS changes and cross-functional change impacts)
- Oversee GxP training framework (curricula, assignment rules, effectiveness checks, compliance reporting)
- Partner with functional owners to define role-based training requirements
- Ensure QMS records are complete, traceable, audit-ready, and meet data integrity principles
- Establish metrics and trending for QMS health (cycle time, overdue items, training compliance)
- Lead QMS simplification/optimization, including CAPA prevention initiatives based on trending and learnings
- Prepare Quality Management Review packages: KPIs, risks, audit outcomes, CAPA effectiveness, and improvement plans
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
