Quality Management System Lead

Summary/Own QMS framework to ensure processes, document control, training, and quality records support consistent compliance across functions and regions.

Your Role:
- Define and maintain QMS structure: policies, SOPs, work instructions, templates, and governance
- Harmonize across GxP domains (GMP/GLP/GCP) and align 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 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 QMS health metrics/trending (cycle time, overdue items, training compliance)
- Lead QMS simplification/optimization and CAPA prevention initiatives based on trending/learned insights
- Prepare Quality Management Review packages (KPIs, risks, audit outcomes, CAPA effectiveness, improvement plans)

What You Bring:
- Bachelor’s degree in Life Sciences, Quality, or related discipline (required)
- Quality-related certification preferred (e.g., ASQ, ISO Lead Auditor, Quality Systems)
- Training in electronic QMS platforms advantageous
- 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, governance; GxP training systems/compliance tracking; data integrity and document control
- Process-oriented, structured, detail-focused; strong communication/training skills; ability to simplify complex processes and drive alignment