Director, Quality Management Systems/Validation & Compliance Lead
Core
Driving GWE R&D Compliance Program and Systems across Global sites, ensuring adherence to cGLPs, cGCPs, and cGMPs while leading continuous improvement strategies.
Role type
Director, Quality Management Systems/Validation & Compliance Lead
Builds
Global functional elements of the Compliance Program including validation, documentation, and training systems
Domain
Pharmaceutical R&D / Quality Management Systems / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategy development, budget management, audit leadership, corrective action verification, stakeholder engagement, regulatory interpretation, program documentation, risk management, team facilitation, financial analysis
Preferred skills
Master's degree, 15+ years in facility management/engineering/compliance, financial management, business continuity planning, senior-level influence, ISO 9000/Malcolm Baldrige experience, Six Sigma, GxP knowledge, multi-disciplinary team management
Technologies
ISO 9000, Malcolm Baldrige, Six Sigma, GxP systems
Responsibilities
Assure compliance for site facility cGLP, cGCP, cGMP systems; manage budget for compliance functions; oversee document management strategy; lead management system audits; verify corrective action requests; engage stakeholders in compliance program development; monitor program effectiveness; lead certification/registration efforts; conduct Site Risk Management Reviews; issue and control compliance procedures; liaise with third-party assessors
Seniority
Director, strategic leadership & global oversight
