GMP Operational Quality Manager
Core
Ensures alignment with corporate goals and compliance with regulatory requirements for GMP manufacturing and analytical testing at contracted suppliers.
Role type
Senior GMP Operational Quality Manager
Builds
Commercial pharmaceutical products (oral solid dosage forms, drug substance, spray dried dispersion)
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, GMP manufacturing oversight, Root Cause Analysis, CAPA management, change control, audit support, electronic document management systems, batch disposition, risk mitigation, cross-functional leadership, project management
Preferred skills
Experience with drug product development, mentoring staff, continuous improvement initiatives
Technologies
Veeva
Responsibilities
Draft and enforce Quality Agreements between CMOs/Suppliers and Vertex; Conduct quality investigations/deviations and review corrective action plans; Approve investigations/CAPAs; Maintain Quality Metrics to support process improvement; Conduct GMP document review; Perform disposition activities in support of Commercial products; Support internal or external audit programs; Provide technical advice for partner and regulatory agency audits
Seniority
Senior, hands-on IC with leadership responsibilities
