Senior Manager, GMP & IT Quality Audits

BioSpace; City of Troy (NY); On-site; USD 126,000 - 206,000; Full time

Job summary

Regeneron, based in Troy, New York, seeks a Senior Manager to join its Quality Assurance internal auditing team. The role provides leadership, strategy, and oversight for GMP, IT, and quality audits that affect GMP operations and products.

You will mentor auditors, manage cross-functional relationships, and drive continual improvement to ensure regulatory compliance and inspection readiness. The position requires a BS/BA in Life Sciences (or equivalent) with 8+ years of experience in quality

Qualifications

• BS/BA in Life Sciences or equivalent with 8+ years of relevant experience.
• Experience with quality systems and auditing.
• Previous leadership/supervisory experience.

Responsibilities

• Lead enterprise audit programs (internal and external) across GMP, IT, and quality: set strategy, build schedules, plan, assign, and personally lead/participate in audits; ensure inspection readiness.
• Provide leadership and subject-matter guidance to auditors; recruit, select, train, and assess external proxy auditors; coach, mentor, and develop internal GMP auditing staff; maintain robust training and qualification programs.
• Develop, maintain, and present metrics and targets (including RTO) to senior leadership to measure strategy execution and the health of quality auditing systems.
• Drive continuous improvement by periodically reassessing auditing processes; translate ambiguity into actionable plans; proactively solve problems to prevent deviations and operational issues.

Skills

Quality auditing

Leadership

Regulatory compliance

Auditing programs

Education

BS/BA Life Sciences

Job description

Regeneron, based in Troy, New York, seeks a Senior Manager to join its Quality Assurance internal auditing team. The role provides leadership, strategy, and oversight for GMP, IT, and quality audits that affect GMP operations and products.

You will mentor auditors, manage cross-functional relationships, and drive continual improvement to ensure regulatory compliance and inspection readiness. The position requires a BS/BA in Life Sciences (or equivalent) with 8+ years of experience in quality