- 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.
Roles & Responsibilities: - 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
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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
