> Markdown version of [/jobs/ext/1888323-information-systems-sr-manager-technology-regulatory-compliance-lead](https://www.wearedevelopers.com/jobs/ext/1888323-information-systems-sr-manager-technology-regulatory-compliance-lead). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Information Systems Sr. Manager - Technology Regulatory Compliance Lead - **Company:** Amgens Mission Of Serving Patients - **Location:** Holly Springs, United States (Remote available) - **Experience:** Expert - **Salary:** $135,442.0 - $183,244.0 - **Contract:** Permanent contract - **Skills:** Software Documentation, Information Systems, Data Integrity, Digital Technology, System Testing, Reliability of Systems, Information Technology, GXP - **Published:** August 1, 2026 - **Apply:** https://www.dice.com/job-detail/c2b4b3cb-4783-4a17-a447-e0b42dba09a0 ## About the Role Doctorate degree and 2 years of Information Systems/Technology and/or Engineering experience OR Master's degree and 4 years of Information Systems/Technology and/or Engineering experience OR Bachelor's degree and 6 years of Information Systems/Technology and/or Engineering experience OR Associate's degree and 10 years of Information Systems/Technology and/or Engineering experience OR High school diploma / GED and 12 years of Information Systems/Technology and/or Engineering experience, * Industry Experience Preferred: Prior experience in biotechnology, pharmaceutical, or related regulated industries is strongly preferred. * Depth knowledge and hand on experience in computer validation, regulatory compliance, inspection readiness. * Bridge Vision and Execution: Translate operational goals into actionable strategies across manufacturing, laboratory, supply chain, quality, engineering, and technology functions using digital technologies, data, advanced analytics. ## Description Let's do this. Let's change the world. In this vital role, you will lead the delivery of high-quality, robust, and reliable digital technologies and services within the Technology Organization, ensuring seamless support for business, project, and daily operations. You will be accountable for the computer systems compliance framework of the technology function, ensuring adherence to global regulatory requirements and Amgen procedures. You will lead the strategy for computer system validation (CSV), regulatory compliance, and inspection readiness for the technology team, proactively driving a culture of quality and continuous compliance. Serving as the Technology Regulatory Compliance Lead, you will ensure alignment with global quality and compliance strategies and maintain a state of constant inspection readiness. Partnering closely with key stakeholders, you will take full ownership of technology services, driving both project execution and operational excellence. Your focus will be on aligning technology solutions with business needs, continuously optimizing approaches to enhance efficiency, and ensuring reliability, service quality, and sustained compliance for our partners. As Senior Manager of the Technology Department for ANC, you will report directly to the ANC Site Technology Lead Director. This role serves as a key member of the site's Technology Leadership Team, driving innovation, operational excellence, quality, compliance, and measurable business impact through strategic technology leadership., * Lead the development and execution of the strategy for computer system validation, regulatory compliance, and sustained inspection readiness for the Technology organization. * Serve as the Technology Regulatory Inspection Lead, ensuring alignment with global quality and compliance strategies. * Drive inspection readiness efforts, including playbooks, SME coaching, system documentation, and readiness dashboards. * Oversee digital platform implementations, ensuring strong planning, resource management, risk mitigation, and financial oversight. * Manage digital technology services, including validation, compliance, data integrity, and system reliability. * Design and implement effective support models, including vendor and third-party management with clear accountability. * Lead cross-functional teams, run key meetings, and present updates to senior leadership. * Deliver technology solutions that improve efficiency, quality, and business alignment. * Proactively manage complex, simultaneous projects and resolve challenges effectively. * Establish performance metrics to drive continuous improvement. * Ensure successful project delivery and promote operational excellence. * Mentor team members and serve as subject matter experts. * Stay current on industry and technology trends and build external networks to benchmark best practices., * Lead Through Influence and Collaboration: Foster strong cross-functional partnerships to build support for initiatives, energize teams, ensure sustained alignment and focus on business priorities and goals. * Think Strategically: Anticipate impacts, adapt to change, and make well-reasoned decisions that drive continuous improvement and support business needs. * Champion Continuous Learning: Stay current with emerging tools and technologies, actively contribute to professional communities, and foster a culture of innovation. * Drive Problem Solving and Innovation: Apply critical thinking and best practices to proactively resolve complex issues and design effective, scalable solutions. * Communicate with Clarity: Demonstrate strong verbal, written, and presentation skills to engage stakeholders, senior management and lead teams effectively. * Decision-Making: Clearly articulates the rationale behind decisions and their potential implications, continuously reflecting on successes and failures to enhance performance and decision-making. * Adaptive Leadership: Recognizes the need for change and actively participates in technical strategy planning. * Balance Priorities: Manage multiple initiatives with strong organizational skills, ensuring alignment with team goals and measurable performance outcomes. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [Exploring 5 Key Applications of AI Abundance with Blockchain Assurance](https://www.wearedevelopers.com/videos/971-exploring-5-key-applications-of-ai-abundance-with-blockchain-assurance) - [How To Test A Ball of Mud](https://www.wearedevelopers.com/videos/173-how-to-test-a-ball-of-mud) - [Startup Presentation: StorX - Future of Cloud Storage](https://www.wearedevelopers.com/videos/1176-startup-presentation-storx-future-of-cloud-storage) - [How I Built QA from Scratch in a Scaling Startup - no fluff real life story](https://www.wearedevelopers.com/videos/2041-how-i-built-qa-from-scratch-in-a-scaling-startup-no-fluff-real-life-story) ## Related Articles - [A Guide to Green Tech and Green IT Careers](https://www.wearedevelopers.com/magazine/374-a-guide-to-green-tech-and-green-it-careers) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Top-Paying Tech Jobs (with Salaries)](https://www.wearedevelopers.com/magazine/372-top-paying-tech-jobs-with-salaries) - [Best Paying Jobs in Technology](https://www.wearedevelopers.com/magazine/256-best-paying-jobs-in-technology) - [From developer to manager – what does it take to become an engineering manager?](https://www.wearedevelopers.com/magazine/42-from-developer-to-manager-what-does-it-take-to-become-an-engineering-manager) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development)