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.
Let’s do this. Let’s change the world. In this vital role you will as an SAP Validation and Compliance Lead will be responsible for the qualification and validation processes for Enterprise Resource Planning (ERP) systems. This role ensures that project delivery and operations meet industry standards and regulatory requirements specific to the Life Sciences sector. As a leader, you will develop and implement comprehensive validation strategies, handle critical documentation, and supervise project plans. You will work closely with cross-functional teams to drive compliance efforts and lead a validation team, ensuring the successful execution of global SAP implementations. Expertise in Agile methodologies will be crucial for integrating these practices into validation processes and project management.
Lead qualification and validation processes for SAP ERP platforms, ensuring adherence to industry standards and regulatory requirements.
Develop and implement validation strategies, including handling key documentation such as Validation Plans, Test Protocols, and Summary Reports.
Lead all aspects of project plans, schedules, and risk management to support successful global SAP implementations.
Collaborate with cross-functional teams to advise on and define validation requirements and ensure comprehensive testing and compliance.
Integrate Agile methodologies into validation processes and project management to enhance efficiency and flexibility.
Drive compliance efforts and maintain high standards through continuous oversight and leadership of the validation team.
We are all different, yet we all use our unique contributions to serve patients.
Master’s degree with 8 - 10 years of experience in Computer Science, Business, Engineering, IT or related field OR
Bachelor’s degree with 10 - 14 years of experience in Computer Science, Business, Engineering, IT or related field OR
Diploma with 14 - 18 years of experience in Computer Science, Business, Engineering, IT or related field
Must-Have Skills:
Experience in the qualification and validation of SAP ERP systems, particularly in regulated environments like Life Sciences.
In-depth knowledge of GxP regulations, with the ability to ensure system integrity and regulatory compliance.
Proficiency in Agile / Scaled Agile Framework (SAFe) methodologies, with experience integrating Agile practices into validation processes and project management.
Proven experience in leading and handling validation teams, with strong skills in staff supervision, development, and fostering a collaborative and continuous learning environment.
Experience with additional technologies such as SAP Business Technology Platform (BTP), SAP Industry Cloud Solution, Veeva Quality Vaults, and ServiceNow.
Experience in handling ERP implementations, including familiarity with agile project management tools and methodologies.
Experience in change management related to system validation, including the ability to handle change requirements, impact assessments, and validation during implementation.
Preferred Qualifications:
Professional Certifications:
Scrum Master (preferred)
SAP certification (preferred)
Leadership and Team Management
Effective Communication
Problem-Solving
Attention to Detail
Adaptability
As we work to develop treatments that deal with 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.
for a career that defies inspiration
Objects in your future are closer than they appear. Join us.