Information Systems Sr. Manager - Technology Regulatory Compliance Lead
amgen
Job description
About the role
Amgen is looking for an Information Systems Sr. Manager to act as Technology Regulatory Compliance Lead for its Technology organization. The role leads the delivery of high-quality, robust and reliable digital technologies and services, supports business, project and daily operations, and owns the computer systems compliance framework so that the technology function meets global regulatory requirements and Amgen procedures. It reports directly to the ANC Site Technology Lead Director and sits in the site's Technology Leadership Team.
Key responsibilities
- Lead the strategy for computer system validation, regulatory compliance and inspection readiness, and drive inspection readiness through playbooks, SME coaching, system documentation and readiness dashboards.
- Oversee digital platform implementations, covering planning, resource management, risk mitigation and financial oversight.
- Manage digital technology services including validation, compliance, data integrity and system reliability.
- Design support models, including vendor and third-party management with clear accountability.
- Lead cross-functional teams, run key meetings and present updates to senior leadership.
- Mentor team members, act as subject matter expert, establish performance metrics and manage complex, simultaneous projects.
Required profile
- One of: doctorate with 2 years of experience, master's with 4 years, bachelor's with 6 years, associate's with 10 years, or high school diploma with 12 years of Information Systems, Technology and/or Engineering experience.
- Prior experience in biotechnology, pharmaceutical or other regulated industries is strongly preferred.
- Depth of knowledge and hands-on experience in computer validation, regulatory compliance and inspection readiness.
What we offer
- Total rewards package: retirement and savings plan with company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, and time-off plans.
- Flexible work models, including remote work where possible.
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Published 5 hours ago
Expires 1 month from now
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