Program Manager – Quality & Compliance Systems - 2847
Core
Leading global Quality & Compliance Systems initiatives within a Life Sciences organization, ensuring regulatory adherence and system modernization.
Role type
Senior Program Manager (Quality & Compliance Systems)
Builds
Global quality systems, regulatory compliance frameworks, and digital transformation initiatives for Life Sciences.
Domain
Life Sciences (Pharmaceuticals, Biotechnology, Medical Devices)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Program Management, eQMS, Digital Quality Transformation, CAPA, Change Control, Document Management, Audit Management, Supplier Quality, Regulatory Compliance, System Validation (CSV/CSA), Risk Management, Stakeholder Management, Budget Management, Global Program Leadership
Preferred skills
Veeva Vault Quality, TrackWise, MasterControl, ETQ Reliance, OpenText Documentum, SAP QM, ServiceNow GRC, Oracle Quality Management, PMP, PgMP, SAFe, ITIL, CQA, CQE, Lean Six Sigma, Agile/Scrum
Technologies
eQMS platforms, ERP, MES, LIMS, CRM, SAP, ServiceNow, Oracle
Responsibilities
Define program objectives, scope, roadmap, and governance aligned with corporate strategy and regulatory requirements; Lead implementation, modernization, and integration of quality systems; Develop program plans, schedules, and budgets; Ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ISO 13485, ALCOA+, CSV, and CSA; Collaborate with cross-functional teams including Quality, Regulatory Affairs, Manufacturing, IT, and R&D; Identify and mitigate regulatory, technical, and operational risks; Manage vendor contracts and SOWs; Lead change management, communication, and user adoption.
Seniority
Senior, hands-on IC
