CSV & Regulatory Compliance Tech Systems Analyst

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Retirement & Savings Plan

Medical, dental & vision coverage

Flexible spending accounts

Job summary

Amgen North Carolina (ANC) Technology seeks a Specialist IS Business Systems Analyst to drive computer validation and regulatory compliance initiatives. You will partner with the business to ensure data integrity and compliant, reliable systems across the technology stack.

You will contribute to strong inspection readiness, collaborate with cross-functional teams, and support digital platform validation with emphasis on quality and continuous improvement.

Qualifications

• Doctorate degree is required to qualify for this role.
• Master’s degree with 2+ years Information Systems or Engineering experience or equivalent.
• 4 years of IS/Engineering experience with a Bachelor’s degree or equivalent.

Responsibilities

• Serve as SME in CSV, regulatory compliance, data integrity, quality systems, and inspection readiness.
• Contribute to development and execution of CSV, regulatory compliance, and inspection readiness strategies.
• Partner with cross-functional teams to align with global quality standards and practices.
• Support inspection readiness activities, including playbooks, SME guidance, and system documentation.
• Provide validation oversight for digital platform implementations and data integrity.
• Collaborate with vendors and third-party providers on validation activities.
• Participate in cross-functional initiatives, delivering stakeholder updates.
• Help deliver solutions that improve efficiency and quality while aligning to business goals.
• Manage multiple priorities and resolve complex compliance challenges.
• Develop and track performance metrics for continuous improvement.
• Support project execution and promote operational excellence.
• Stay current with industry trends and regulatory expectations.

Skills

CSV

Regulatory compliance

Data integrity

Quality systems

Inspection readiness

Education

Doctorate degree

Masters degree + 2 yrs IS/Eng

Bachelors degree +4 yrs IS/Eng

Associates degree +8 yrs IS/Eng

High school diploma +10 yrs IS/Eng

Tools

Job description

Amgen North Carolina (ANC) Technology seeks a Specialist IS Business Systems Analyst to drive computer validation and regulatory compliance initiatives. You will partner with the business to ensure data integrity and compliant, reliable systems across the technology stack.

You will contribute to strong inspection readiness, collaborate with cross-functional teams, and support digital platform validation with emphasis on quality and continuous improvement.