Computer System Validation Jobs in North Carolina

Join Amgen's Mission of Serving Patients

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.

Information Systems Sr. Manager - Technology Regulatory Compliance Lead

Live

What you will do

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.

Responsibilities:

• 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.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.

Basic Qualifications:

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

Preferred Qualifications:

• 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.
• 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.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receivea sufficient numberor select a candidate for the position.

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 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 accommodation.

Salary Range