Specialist IS Business Systems Analyst (Computer System Validation)

Location: Holly Springs, North Carolina, United States

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Serve as a subject matter expert in computer system validation, regulatory compliance, data integrity, quality systems, and inspection readiness.
• Develop and execute strategies for validation, compliance, and sustained inspection readiness, including playbooks, guidance, documentation, and tracking tools.
• Provide validation and compliance oversight for digital platform implementations, including planning, risk identification, system reliability, and regulatory alignment.
• Partner with business teams, system owners, vendors, and cross-functional stakeholders to analyze processes, identify bottlenecks, and recommend compliant solutions.
• Support the computerized systems lifecycle through requirements gathering, process and system analysis, integration planning, and design approaches.
• Track performance metrics, support continuous improvement, and resolve complex compliance and validation challenges.

Requirements

• Doctorate degree; or a master's degree and 2 years of Information Systems or Engineering experience; or a bachelor's degree and 4 years of experience; or an associate's degree and 8 years of experience; or a high school diploma/GED and 10 years of experience.
• In-depth knowledge and hands-on experience in computer system validation, regulatory compliance, and inspection readiness.
• Strong verbal, written, and presentation skills for engaging stakeholders, senior management, and cross-functional teams.
• Critical thinking, structured decision-making, problem-solving, and the ability to manage multiple priorities.
• Onsite role based in Holly Springs, North Carolina, United States.

Nice to have

• Experience in biotechnology, pharmaceutical, or another regulated industry.
• Experience with technical strategy planning, automated compliant solutions, and support models involving vendors or third-party providers.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Medical, dental, and vision coverage, plus life and disability insurance.
• Retirement and savings plan with company contributions and flexible spending accounts.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and flexible work models where applicable.