IT Quality -Senior Manager – Computerized Systems Validation /Assurance & AI

Position Summary

Join Amgen’s mission of serving patients by providing strategic leadership, quality oversight, and global process stewardship for GxP computerized systems, AI-enabled technologies, and emerging digital solutions.

The Senior Manager, Global IT Quality, Computerized Systems Validation & AI Assurance is responsible for advancing risk-based validation practices, Computer Software Assurance (CSA), AI validation and qualification frameworks, inspection readiness, and continuous improvement initiatives across the enterprise. This role ensures computerized systems and AI-enabled solutions remain compliant, validated, and maintained in a state of control throughout their lifecycle.

The position partners closely with Business Owners, System SMEs, IT Application Owners, AI Model SMEs, Digital Technology & Innovation teams, and the Global Business Process Owner (BPO) for Responsible Use of AI in GxP to ensure AI-enabled systems are validated, qualified, governed, and maintained in accordance with Amgen’s Quality Management System (QMS), global regulatory requirements, and industry best practices.

The individual will be required to work from our office located in Hyderabad, India (Amgen India-AIN). The candidate will be required to work from the office as dictated by site policy.

As a Senior Manager within the IT Quality organization, you will provide leadership, strategic direction, and quality oversight for teams supporting various phases of the Information Systems Lifecycle within a GxP-regulated environment.

Leadership Responsibilities

• Responsible for managing and developing a high-performing team, providing leadership and guidance on Quality, Computerized Systems Validation, CSA, AI Validation, and GxP compliance activities.
• Provide strategic leadership and quality oversight for computerized systems validation, AI validation, and digital quality initiatives.
• Drive organizational adoption of risk-based validation and Computer Software Assurance (CSA) methodologies.
• Lead cross-functional initiatives supporting AI readiness, emerging technology governance, and digital transformation.
• Coach, mentor, and develop quality professionals and project teams.
• Represent IT Quality in governance forums, inspections, audits, and strategic initiatives.

Project / Program Management

• Work with leadership teams to define success measures, KPIs, and quality metrics for computerized systems and AI-enabled solutions.
• Establish and monitor program performance indicators to drive operational excellence and continuous improvement.
• Lead strategic initiatives related to AI readiness, digital transformation, computerized systems compliance, and emerging technologies.
• Prepare analytics, dashboards, and performance reports to evaluate effectiveness of operational plans and quality processes.
• Collaborate with global stakeholders to align business objectives, quality requirements, and regulatory expectations.
• Identify operational inefficiencies and implement improvements to streamline workflows and increase productivity.
• Present quality performance, risk assessments, compliance trends, and strategic recommendations to senior leadership.
• Utilize data-driven insights to support decision-making and continuous improvement initiatives.

Project Focus Areas

Computerized Systems Validation & Computer Software Assurance (CSA)

• Provide quality oversight for validation, qualification, and lifecycle management of GxP computerized systems, ensuring compliance with regulatory requirements and Quality Management System (QMS) expectations.
• Drive implementation and continuous improvement of Computer Software Assurance (CSA) methodologies to focus assurance activities on critical risks and intended use.
• Support validation and compliance activities for ERP (SAP/S4 HANA), LIMS, ELN, CDS, MES, QMS, Veeva Vault, TrackWise, cloud-hosted platforms, and other GxP-regulated systems.
• Guide risk-based decision-making related to computerized systems and digital technologies.
• Ensure effective change control, audit trail review, periodic review, data integrity, and validation maintenance practices are implemented and sustained.
• Partner with system owners, technology teams, and quality stakeholders to ensure systems remain inspection-ready and compliant throughout their lifecycle.

AI Validation & Qualification

• Lead and continuously improve the global AI validation and qualification framework for AI-enabled systems used in GxP-regulated activities.
• Partner with the Global Business Process Owner (BPO) for Responsible Use of AI to ensure alignment between AI validation requirements, governance expectations, and regulatory obligations.
• Establish risk-based approaches for AI trustworthiness, model credibility, explainability, monitoring, transparency, and human oversight controls.
• Support development and implementation of validation frameworks for Artificial Intelligence (AI), Machine Learning (ML), Generative AI, and Large Language Model (LLM)-enabled systems.
• Collaborate with AI Model SMEs, Data Scientists, Technology Teams, and Business Process Owners to ensure AI solutions meet validation, compliance, and quality expectations.
• Support implementation of controls related to human oversight, independent verification, traceability, auditability, data integrity, and ongoing performance monitoring.
• Maintain awareness of evolving regulatory requirements related to AI and emerging technologies and assess their impact on quality systems and validation processes.
• Contribute to the development and maintenance of global procedures, templates, standards, and guidance documents supporting AI validation and qualification processes.
• Drive AI readiness initiatives and build organizational competencies within the IT Quality organization.

Quality Management & Compliance

• Ensure Quality Management System (QMS) requirements remain aligned with evolving regulatory expectations and industry best practices.
• Review and approve SOPs, quality records, deviations, CAPAs, change controls, and validation-related documentation in accordance with procedural requirements.
• Support supplier qualification and vendor oversight activities for computerized systems, software applications, and AI-enabled technologies.
• Drive inspection readiness and audit preparedness activities across regulated computerized systems and AI-enabled solutions.
• Support regulatory inspections, internal audits, supplier audits, and compliance assessments as required.
• Analyze quality trends, compliance metrics, audit observations, and inspection outcomes to identify improvement opportunities and mitigate risks.
• Ensure appropriate policies, procedures, templates, and supporting documentation are maintained to support compliance with applicable regulations and quality standards.

Key Responsibilities

• Assess regulatory and compliance risks associated with implementation and lifecycle management of computerized systems and AI-enabled technologies.
• Collaborate effectively with Business Owners, Technology Leads, System SMEs, Data Science teams, and Quality stakeholders to ensure delivery of compliant and high-quality outcomes.
• Leverage analytical tools and business intelligence platforms to monitor quality performance and identify improvement opportunities.
• Independently develop practical, risk-based solutions consistent with business objectives and quality expectations.
• Communicate quality risks, compliance concerns, strategic recommendations, and improvement opportunities to management and stakeholders.

Qualifications & Skills

Education & Experience

• Master’s degree with a minimum of 12 years of experience in Quality Assurance, Computerized Systems Validation (CSV), IT Quality, Software Quality Assurance, or related regulated environments; OR
• Bachelor’s degree with a minimum of 14 years of relevant experience.
• Demonstrated experience leading global programs, strategic initiatives, and cross-functional teams within GxP-regulated environments.
• Experience supporting and providing quality oversight for regulated systems such as SAP/S4 HANA, LIMS, ELN, CDS, MES, QMS, Veeva Vault, TrackWise, cloud-hosted platforms, and other GxP computerized systems.
• Experience supporting AI-enabled systems used in GxP-regulated environments, including validation, qualification, lifecycle management, and governance processes.
• Experience influencing senior stakeholders and driving enterprise-wide quality, compliance, or digital transformation initiatives.

Technical Knowledge

Strong knowledge of:

• GxP Computerized Systems Validation (CSV)
• Computer Software Assurance (CSA)
• Risk-Based Validation Methodologies
• Quality Management Systems (QMS)
• Data Integrity Principles
• Change Control, CAPA, Deviation Management, and Audit Trail Review Processes

Working knowledge of:

• Artificial Intelligence (AI), Machine Learning (ML), Generative AI, and Large Language Models (LLMs)
• AI Validation and Qualification Approaches
• AI Trustworthiness and Credibility Assessment Methodologies
• AI Governance and Human Oversight Controls
• AI System Lifecycle Management Concepts

Familiarity with:

• EU AI Act
• FDA AI/ML Guidance and Computer Software Assurance (CSA)
• GAMP® 5 Second Edition
• 21 CFR Part 11
• EU Annex 11
• NIST AI Risk Management Framework (AI RMF)
• ISO 42001
• Data Integrity Guidance and GxP Requirements

Leadership & Business Skills

• Strong leadership skills with the ability to influence and collaborate across global, cross-functional teams and stakeholders.
• Proven ability to manage multiple strategic initiatives simultaneously and successfully deliver against timelines.
• Strong analytical and problem-solving skills with the ability to evaluate complex situations and develop practical, risk-based solutions.
• Ability to interpret quality, operational, and compliance metrics and translate findings into actionable improvement plans.
• Excellent communication, negotiation, facilitation, stakeholder management, and presentation skills.
• Experience coaching, mentoring, and developing teams.
• Ability to drive continuous improvement initiatives through data analysis, trend evaluation, industry benchmarking, and business insights.
• Ability to operate effectively in a matrixed organization and collaborate across global teams and multiple time zones.

Tools & Technologies

• Proficiency with ServiceNow, Jira, Confluence, HP ALM, Veeva Vault, TrackWise, and other validation and quality management platforms.
• Experience with Agile, DevOps, CI/CD, and cloud-native technologies.
• Proficiency in Smartsheet and Business Intelligence platforms, including Power BI, Tableau, and Spotfire.
• Familiarity with AI-enabled platforms, model monitoring tools, and digital quality solutions supporting regulated business processes.