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 ECCS 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 PROSPECT 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 Apply now for a career that defies imagination Objects in your future are closer than they appear Join us careers amgen com

📌 Sap Validation And Compliance Manager (Telangana)
🏢 AMGEN
📍 Telangana