SAP Validation and Compliance Manager

India

SAP Validation and Compliance Manager

Role Name: Specialist IS Bus Sys Analyst

Department Name: SAP Validation and Compliance

Role GCF: 05A

Join Amgen’s Mission of Serving Patients

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

SAP Validation and Compliance Manager

What you will do

Let’s do this. Let’s change the world. In this vital leadership role, you will manage and drive the qualification, validation, and compliance activities for Amgen’s SAP ERP systems and platforms. You will ensure that enterprise-wide ERP solutions meet regulatory requirements, industry standards, and Amgen’s 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

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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.