QA System Integration Manager (3 years contract)
Core
Leading the end-to-end integration and harmonization of Quality Management System (QMS) procedures, processes, and systems across manufacturing sites, specifically integrating a non-Abbott facility into an Abbott facility.
Role type
Senior Quality System Integration Manager
Builds
Sustainable, inspection-ready Quality System architectures and operational practices
Domain
Healthcare manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS) lifecycle management, procedure and process governance, program execution, dependency management, change management, stakeholder influencing, risk assessment, audit and inspection readiness, regulatory compliance knowledge
Preferred skills
Experience as a Quality System Owner or Process Owner, experience in pharmaceuticals/medical devices/nutrition industries, ability to manage ambiguity and complexity
Technologies
QMS software platforms, enterprise document management systems, project management tools
Responsibilities
Lead end-to-end integration of QMS procedures and supporting systems across sites and functions; Oversee development, revision, approval, and deployment of SOPs aligned with enterprise QMS standards; Partner with Quality System Owners to define current-state gaps and future-state architectures; Lead execution of assigned QMS integration workstreams within larger programs; Serve as coordination point for QMS integration across Quality, Manufacturing, Engineering, Supply Chain, IT, Regulatory, and Training; Lead change management for QMS updates ensuring user adoption and effectiveness checks; Ensure integration activities meet regulatory and internal compliance expectations; Track and report progress, risks, and outcomes of QMS integration efforts
Seniority
Senior, hands-on IC with program leadership