Manager, Quality Engineering
Core
Leads independent oversight of site validation programs and governance of plant data integrity to ensure compliance with cGMP and regulatory standards.
Role type
Manager, Quality Engineering (Validation & Data Integrity)
Builds
Compliant validation programs and data integrity governance frameworks for manufacturing sites
Domain
Healthcare / Medical Devices / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (validation & data integrity systems)
Required skills
cGMP validation, computerized-system assurance, GAMP 5, 21 CFR Part 11, ALCOA+ principles, data integrity governance, risk-based decision-making, people leadership, strategic planning, regulatory inspection management
Preferred skills
Six Sigma, statistics, process capability, electronic quality systems, complex program remediation
Technologies
GAMP 5, 21 CFR Part 11, ALCOA+, electronic quality systems
Responsibilities
Establish site strategy and governance model for independent QA oversight; Lead and performance-manage the Quality Engineering team; Approve validation master plans, high-risk protocols, and critical deviations; Chair validation and data integrity governance forums; Represent programs during FDA and regulatory inspections; Develop capability and succession plans for the team
Seniority
Manager, people and program leadership
