Manager, QA, Data Integrity Program Manager
Core
Support the site's Data Integrity (DI) program at a biologics manufacturing site to ensure product quality, patient safety, and regulatory compliance.
Role type
Manager, Data Integrity Program
Builds
Sustainable state of compliance and ALCOA+ principles across GMP manufacturing processes
Domain
Biologics manufacturing / Pharmaceutical Quality / GMP
Deliverable
dashboards & analysis
Required skills
Data Integrity governance, ALCOA+ principles, GMP processes, deviations management, investigations, CAPAs, change controls, quality risk assessments, audit support, computerized systems (CSV)
Preferred skills
Audit/inspection experience, regulatory interaction experience
Technologies
Computerized Systems (CSV)
Responsibilities
Support DI governance and implementation of DI standards, promote DI awareness through training and coaching, plan and execute DI Walkthroughs, coordinate DI assessments and remediation, provide DI support for deviations/investigations/CAPAs/audits, deputize the DI Community
Seniority
Manager, hands-on IC