Director– Quality Management Systems (QMS) & Digital Quality Governance
Core
Architect, modernize, and deploy a digitized Quality Management System (QMS) for next-generation QC testing, laboratory automation, and end-to-end analytical digitization.
Role type
Director, Quality Management Systems & Digital Quality Governance
Builds
Modernized, digitized QMS platforms integrated with automated laboratory workflows, LIMS, ELN, and digital data pipelines.
Domain
Pharmaceutical/Biopharmaceutical manufacturing and Quality Control (cGMP)
Required skills
QMS architecture, CAPA, deviation management, risk management (ICH Q9), computerized systems validation (CSV/CSA), Data Integrity by Design (ALCOA+), regulatory compliance (21 CFR Part 11/210/211, EU Annex 11), program governance, change management, cross-functional leadership.
Preferred skills
QMS transformation, automated testing platforms, robotics, Lean/Six Sigma, programming.
Technologies
TrackWise, Veeva Vault QMS, LIMS, ELN, CDS, SDMS, automated instrumentation.
Responsibilities
Define and execute QMS integration strategy for lab transformation; oversee eQMS code review and compliance; embed Data Integrity and CSA principles; ensure regulatory compliance and inspection readiness; direct QMS workstream governance; drive change management and training; serve as central quality authority; supervise quality specialists and consultants.
Seniority
Director, strategic & operational leadership
