CSV & Compliance Specialist for Inspection-Ready Systems

NCBiotech; Holly Springs (NC); On-site; USD 110,000 - 149,000; Full time

Job summary

Amgen North Carolina's Technology team seeks a Specialist IS Business Systems Analyst – CSV SME to drive compliance and validation across digital platforms. You will act as SME in CSV, regulatory compliance, data integrity, quality systems, and inspection readiness.

Collaborate with cross-functional teams to maintain compliant systems, develop playbooks, and support regulatory expectations. The role reports to the ANC Technology Regulatory Compliance Lead, Senior Manager and offers a

Qualifications

• Doctorate or Master’s with IS/Engineering experience; alternative degrees with years of experience accepted.
• Broad knowledge of computer validation, regulatory compliance, inspection readiness.
• Ability to communicate clearly with stakeholders and manage multiple priorities.

Responsibilities

• Serve as SME in CSV, regulatory compliance, data integrity, quality systems, and inspection readiness.
• Develop and execute strategies supporting CSV, compliance, and ongoing readiness.
• Collaborate with cross-functional teams to ensure alignment with global quality standards.

Skills

CSV knowledge

Regulatory compliance

Data integrity

Quality systems

Inspection readiness

Cross-functional collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Documentation tools

Regulatory databases

Job description

Amgen North Carolina's Technology team seeks a Specialist IS Business Systems Analyst – CSV SME to drive compliance and validation across digital platforms. You will act as SME in CSV, regulatory compliance, data integrity, quality systems, and inspection readiness.

Collaborate with cross-functional teams to maintain compliant systems, develop playbooks, and support regulatory expectations. The role reports to the ANC Technology Regulatory Compliance Lead, Senior Manager and offers a