Senior Manager, AIN Documentation, Content Create and Automation (DCCA)
Core
Lead a global GMP documentation service team in India to create, revise, and manage controlled documentation for Amgen manufacturing sites worldwide, ensuring compliance and SLA delivery.
Role type
Senior Manager, GMP Documentation Service Delivery
Builds
Controlled GMP documents (SOPs, work instructions, forms, records) and training materials for global manufacturing sites
Domain
Pharmaceutical manufacturing / Quality Management Systems (GMP)
Required skills
GMP compliance, technical writing, service delivery management, capacity planning, team leadership, change control, audit readiness, stakeholder management, operational excellence, budget management
Preferred skills
Life sciences background, shared service model experience, electronic document management systems, Lean/continuous improvement, project management
Technologies
Electronic document management systems, Quality management systems
Responsibilities
Lead daily operations of global GMP documentation service; Establish intake, triage, and prioritization practices; Develop capacity plans and staffing models; Ensure compliance with global and local GMP requirements; Recruit and develop high-performing documentation teams; Standardize workflows and drive continuous improvement; Manage departmental budgets and resources
Seniority
Senior, hands-on IC
