Director of Risk Management

Job Summary

Leading critical programs for BLA submission and commercial launch, the full-time Director of Risk Management will own the enterprise risk management and inspection readiness initiatives, ensuring effective risk mitigation and preparation for FDA inspections in a hybrid work environment.

Key Responsibilities

• Own and mature the enterprise risk management (ERM) program, including risk assessments and reporting to executive leadership
• Lead the cross-functional inspection readiness program, executing gap assessments and driving remediation efforts
• Present risk and readiness status to senior leadership and governance committees, fostering a culture of risk awareness

Required Qualifications

• Bachelor's degree in life sciences, engineering, or a related field; advanced degree preferred
• 10+ years of experience in biotech/pharmaceutical quality, compliance, or risk management, with 3+ years in a leadership role
• Direct experience preparing for and managing FDA inspections (PAI, PLI, and/or BIMO)
• Working knowledge of ICH Q9/Q10, 21 CFR Parts 210/211/600, and quality risk management methodologies
• Experience with CDMO/external manufacturing oversight and supplier quality risk management