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 curricula, performance expectations, career paths, and succession plans that build sustainable technical and leadership capability in India.
Promote a culture of quality, ownership, collaboration, customer focus, and continuous learning while maintaining an inclusive, respectful, and accountable work environment.
Partner with Human Resources and functional leaders to maintain an adaptable organization that can respond to changing global demand and business priorities.
Operational Excellence and Strategic Improvement
Standardize and continuously improve documentation workflows, templates, authoring practices, quality controls, and digital ways of working across the service.
Lead cross-site projects and improvement initiatives that increase speed, accuracy, scalability, and customer experience without compromising compliance.
Manage departmental headcount, training, technology, and operating budgets; optimize resources against the long-range demand plan.
Represent the documentation service on global teams, task forces, and quality-system initiatives as needed.
Service Performance and Quality Measures
The leader establishes goals and management routines that keep customer commitments, documentation quality, and compliance visible and balanced.
Measure
Leadership expectation
On-time delivery
Meet committed site service-level agreements through active planning, workload balancing, and early escalation of risks.
Right-first-time quality
Increase documents accepted without material rework by applying defined authoring standards, peer review, and quality checks before handoff.
Cycle time and queue health
Monitor turnaround time, aging, backlog, and prioritization to maintain a predictable global service.
Compliance performance
Maintain adherence to controlled-document, change-control, data-integrity, training, and audit-readiness requirements.
Customer partnership and capacity
Use site feedback, demand forecasts, and workload data to improve service reliability and plan resource needs.
Service-level targets and acceptance criteria are defined in collaboration with the supported sites and governing quality processes.
Basic Qualifications
Bachelor's degree and 12 to 17 years of experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
Preferred Qualifications
Bachelor's degree in life sciences, engineering, technical communications, business, or a related field.
7+ years of directly related experience in a biotechnology, pharmaceutical, medical-device, or other regulated GMP environment, including 4+ years leading people, technical writers, documentation specialists, projects, or programs.
Demonstrated experience developing and revising controlled GMP documents, including SOPs, work instructions, forms, manufacturing or laboratory records, and related technical documentation.
Experience operating a shared service or customer-facing function across multiple sites, cultures, and time zones, with accountability for service-level agreements and delivery metrics.
Experience with electronic document-management and quality-management systems, document lifecycles, change control, and inspection or audit support.
Lean, continuous-improvement, project-management, or operational-excellence experience is preferred.
Core Competencies
Strong people leadership, coaching, talent development, and capability building for a diverse technical team.
Expert technical writing, editing, and review skills; sound judgment to distinguish content clarity, document quality, and compliance risk.
In-depth knowledge of cGMP, good documentation practices, data integrity principles, controlled-document requirements, and change-management processes.
Service-management discipline: intake, prioritization, workload planning, capacity modeling, performance dashboards, and timely risk escalation.
Ability to influence global stakeholders, resolve competing priorities, communicate clearly in writing and verbally, and operate effectively across time zones.
Analytical problem solving, continuous-improvement mindset, strong attention to detail, and the ability to manage change without compromising quality while demonstrating a commitment to safety, quality, integrity, and Amgen values.
.
