SAP Validation and Compliance Manager

• *What you will do*

In this vital leadership role, you will manage and drive the qualification, validation, and compliance activities for Amgens SAP ERP systems and platforms. You will ensure that enterprise-wide ERP solutions meet regulatory requirements, industry standards, and Amgens IT-QMS policies, while building strong validation capabilities and fostering a culture of continuous compliance.

• Lead and manage a team of validation and compliance professionals responsible for SAP ERP systems (ECC, S/4HANA, BTP, GRC, Boundary systems and related platforms).
• Define, oversee, and continuously improve validation and compliance strategies, aligning with CSA (Computer Software Assurance), GxP Principles, GAMP 5, Annex 11, and 21 CFR Part 11 requirements.
• Drive the planning, execution, and approval of validation deliverables (Ex., Validation Plan, Requirements, Specifications, IQ, OQ, PQ/UAT Test scripts, Validation Report etc.).
• Ensure ongoing operational compliance of the SAP ERP landscape, including Incident Management, Problem Management, Change Control, CAPA, and Deviation processes aligned to Amgen Procedures.
• Provide strategic guidance and subject matter expertise during SAP upgrades, enhancements, integrations, and digital transformation programs.

• Partner with cross-functional teams (ERP, SME, Technology, Quality and Business stakeholders) to embed validation and compliance into project lifecycles and day-to-day operations.

• Proactively monitor and manage system data integrity, audit trails, user access reviews (UARs), and Periodic reviews.

• Champion adoption of digital validation, automation, and AI-driven compliance initiatives to increase efficiency and reduce human error.
• Develop frameworks, templates, and best practices to ensure consistency, scalability, and audit-readiness across all SAP validation and compliance activities.
• Serve as the primary audit liaison for SAP ERP systems, representing IT Compliance during internal and external inspections (ex: FDA, EMA, MHRA).
• Lead audit preparation, respond to regulator queries, ensure timely remediation of findings, and demonstrate end-to-end compliance of validation, incident, change, CAPA, and deviation processes.

• Mentor, coach, and develop team members while fostering a Community of Practice (CoP) to share knowledge and advance SAP compliance maturity.

  *What we expect of you*

We are all different, yet we all use our unique contributions to serve patients.

*Basic Qualifications and Experience:*

• Any degree and 8-13 years of Computer Science, IT or Computerized systems Validation/Assurance experience
• At least 3 years of leadership or people management experience in a regulated IT environment.
• Extensive experience in SAP ERP validation and compliance within a GxP environment.
• Strong knowledge of regulatory compliance standards (21 CFR Part 11, Annex 11, ALCOA+, GAMP 5) and Risk Based Validation Practices aligned to CSA concepts.
• Demonstrated expertise in managing Incident, Problem, Change, CAPA, and Deviation processes within SAP ERP systems.

Preferred Qualifications:

• Demonstrated success in leading SAP ERP validation and compliance efforts during major transformation programs (e.g., ECC S/4HANA upgrade).
• Proven experience in preparing for and facing regulatory inspections for SAP systems.
• Experience with Agile / Scaled Agile Framework (SAFe) methodologies for software delivery.
• Hands-on experience with validation and ITSM tools (e.g., ServiceNow, Digital Validation Tools, Veeva CDOCs, ALM/VM/Test Tools, JIRA)

Professional Certifications

• Scrum Master, or equivalent project management certification
• SAP certification (preferred)
• GAMP 5 / CSA training or certification

*Soft Skills:*

• Strong leadership and team development capabilities, with a track record of building and inspiring high-performing teams
• Excellent stakeholder management, influencing, and communication skills
• Strategic thinker with ability to translate compliance requirements into business-aligned solutions
• Skilled in balancing regulatory rigor with operational efficiency and innovation