Senior Manager, AIN Documentation, Content Create and Automation (DCCA) at Amgen in Hyderabad

Job description

Career Category Manufacturing Job Description Senior Manager, AIN Documentation, Content Create and Automation (DCCA) Location: India | Scope: Global service supporting Amgen sites Under minimal direction, the Senior Manager, DCCA leads a DS, DP or FDP team based in India that creates and revises controlled GMP documentation for Amgen sites globally. The role owns the service-delivery model that enables reliable, compliant, and accurate documentation support - delivering to agreed service-level agreements while driving right-first-time quality, predictable turnaround, and continuous improvement. Hours for this role may vary based on global time zones, which could include hybrid hours, on call requirements, and flexible working hours. Role Responsibilities Global Service Delivery and SLA Management · Lead the daily operation of the global GMP documentation service for DS, DP, or FDP, ensuring requests are received, clarified, prioritized, assigned, completed, and handed off in accordance with defined service-level agreements. · Establish transparent intake, triage, prioritization, and escalation practices that balance site criticality, compliance risk, business impact, and available capacity. · Develop and maintain capacity plans, workload forecasts, staffing models, and recovery plans that enable the team to meet commitments across supported sites and time zones. · Own performance management routines and dashboards for on-time delivery, right-first-time quality, cycle time, queue aging, rework, customer feedback, and resource utilization. · Identify service risks early, communicate impacts and options clearly, and escalate constraints with proposed mitigation and recovery actions. GMP Documentation Quality and Compliance · Ensure document creation and revision activities comply with applicable global and local GMP requirements, good documentation practices, data-integrity expectations, controlled-document procedures, and approved change-control processes. · Set and maintain standards for document structure, technical writing, accuracy, traceability, version control, formatting, and review readiness to prevent defects before delivery. · Oversee authoring and revision of controlled GMP documents, such as SOPs, work instructions, forms, manufacturing and laboratory records, technical reports, and associated attachments, based on approved site inputs and change requirements. · Oversee the content creation of training materials used in the manufacturing areas including instructional design. · Implement appropriate peer review, quality checks, training, and escalation mechanisms to improve right-first-time acceptance and reduce avoidable rework. · Support inspection and audit readiness; ensure service records, training, and performance evidence are complete, traceable, and review-ready. · Oversee investigational support within the specific manufacturing domain. Global Partnership and Governance · Serve as the senior-manager-level liaison between the India documentation team and global site stakeholders, including Manufacturing, Quality, Engineering, QC, Regulatory, Supply Chain, and other technical functions. · Create effective governance forums with supported sites to review demand, priorities, service performance, quality trends, capacity needs, and improvement opportunities. · Clarify and maintain accountability between the service team and site owners: the service team provides disciplined document development and revision support; site functions retain ownership of technical content, approvals, local requirements, and implementation decisions. · Resolve complex cross-functional issues that could affect document quality, approval readiness, delivery timing, or compliance, using a risk-based approach. People Leadership and Organizational Capability · Recruit, develop, coach, and retain a high-performing team of GMP documentation professionals, technical writers, and/or documentation specialists. · Establish role clarity, training