Senior Quality Compliance Specialist (CVRM)

TL;DR

Senior Quality Compliance Specialist (CVRM): Leading the design and implementation of Quality Risk Management and Data Integrity initiatives for a new high-volume drug manufacturing facility with an accent on risk-based operational controls and GxP compliance. Focus on chairing the Change Review Board, ensuring data integrity in automated systems, and fostering a proactive quality culture during the site's ramp-up phase.

Location: Must be based in Holly Springs, North Carolina

Salary: $94,000–$174,600

Company

hirify.global, a member of the Roche group, is a pioneer in the biotechnology industry dedicated to developing groundbreaking medicines for serious and life-threatening diseases.

What you will do

• Lead the site's Quality Risk Management (QRM) program, facilitating complex risk assessments using methodologies like FMEA and PHA.
• Take full ownership of the Data Integrity program, ensuring compliance for all automated, digital, and analytical systems.
• Chair the site Change Review Board to evaluate and approve high-impact modifications during commissioning and validation.
• Provide technical leadership to resolve compliance issues and support core quality systems including inspections and supplier management.
• Partner cross-functionally with Engineering, Operations, and Global teams to integrate risk-based principles into operational design.

Requirements

• Bachelor's degree in a scientific or technical discipline required.
• Minimum 8–10 years of experience in a GxP environment.
• At least 4 years of experience leading QRM, Data Integrity, or Change Control programs in manufacturing.
• Deep knowledge of global GxP regulations (FDA, EMA, ICH, ISO) for sterile drug product manufacturing.
• Proven success in auditing or implementing site-wide Data Integrity programs in highly automated facilities.
• Must be able to work onsite in Holly Springs, NC; relocation assistance is not available.

Culture & Benefits

• Opportunity to launch a state-of-the-art $2B greenfield manufacturing facility from the ground up.
• Work in a fast-paced, entrepreneurial environment focused on next-generation metabolic medicines.
• Comprehensive benefits package including health insurance and retirement plans.
• Commitment to a culture of transparency, solution-oriented dialogue, and operational excellence.