SAP Validation and Compliance Manager
Amgen
SAP Validation and Compliance Manager
Job Description
SAP Validation and Compliance Manager
What you will do
- 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
- 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.
- 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
Must-Have 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
- Competitive benefits
- Collaborative culture
- Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Compensation
8-13
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
30,000 - 50,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong leadership and team development capabilities, with a track record of building and inspiring high-performing teamsintermediate
- Excellent stakeholder management, influencing, and communication skillsintermediate
- Strategic thinker with ability to translate compliance requirements into business-aligned solutionsintermediate
- Skilled in balancing regulatory rigor with operational efficiency and innovationintermediate
Required Qualifications
- Any degree and 8-13 years of Computer Science, IT or Computerized systems Validation/Assurance experience (experience)
- At least 3 years of leadership or people management experience in a regulated IT environment. (experience)
- Extensive experience in SAP ERP validation and compliance within a GxP environment. (experience)
- Strong knowledge of regulatory compliance standards (21 CFR Part 11, Annex 11, ALCOA+, GAMP 5) and Risk Based Validation Practices aligned to CSA concepts. (experience)
- Demonstrated expertise in managing Incident, Problem, Change, CAPA, and Deviation processes within SAP ERP systems. (experience)
- Demonstrated success in leading SAP ERP validation and compliance efforts during major transformation programs (e.g., ECC → S/4HANA upgrade). (experience)
- Proven experience in preparing for and facing regulatory inspections for SAP systems. (experience)
- Experience with Agile / Scaled Agile Framework (SAFe) methodologies for software delivery. (experience)
- Hands-on experience with validation and ITSM tools (e.g., ServiceNow, Digital Validation Tools, Veeva CDOCs, ALM/VM/Test Tools, JIRA) (experience)
- Professional Certifications: Scrum Master, or equivalent project management certification (experience)
- SAP certification (preferred) (experience)
- GAMP 5 / CSA training or certification (experience)
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.
Benefits
- general: Competitive benefits
- general: Collaborative culture
- general: Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Tags & Categories
SAP Validation and Compliance Manager
Amgen
SAP Validation and Compliance Manager
Job Description
SAP Validation and Compliance Manager
What you will do
- 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
- 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.
- 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
Must-Have 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
- Competitive benefits
- Collaborative culture
- Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Compensation
8-13
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
30,000 - 50,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong leadership and team development capabilities, with a track record of building and inspiring high-performing teamsintermediate
- Excellent stakeholder management, influencing, and communication skillsintermediate
- Strategic thinker with ability to translate compliance requirements into business-aligned solutionsintermediate
- Skilled in balancing regulatory rigor with operational efficiency and innovationintermediate
Required Qualifications
- Any degree and 8-13 years of Computer Science, IT or Computerized systems Validation/Assurance experience (experience)
- At least 3 years of leadership or people management experience in a regulated IT environment. (experience)
- Extensive experience in SAP ERP validation and compliance within a GxP environment. (experience)
- Strong knowledge of regulatory compliance standards (21 CFR Part 11, Annex 11, ALCOA+, GAMP 5) and Risk Based Validation Practices aligned to CSA concepts. (experience)
- Demonstrated expertise in managing Incident, Problem, Change, CAPA, and Deviation processes within SAP ERP systems. (experience)
- Demonstrated success in leading SAP ERP validation and compliance efforts during major transformation programs (e.g., ECC → S/4HANA upgrade). (experience)
- Proven experience in preparing for and facing regulatory inspections for SAP systems. (experience)
- Experience with Agile / Scaled Agile Framework (SAFe) methodologies for software delivery. (experience)
- Hands-on experience with validation and ITSM tools (e.g., ServiceNow, Digital Validation Tools, Veeva CDOCs, ALM/VM/Test Tools, JIRA) (experience)
- Professional Certifications: Scrum Master, or equivalent project management certification (experience)
- SAP certification (preferred) (experience)
- GAMP 5 / CSA training or certification (experience)
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.
Benefits
- general: Competitive benefits
- general: Collaborative culture
- general: Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Tags & Categories