Director of Compliance and Quality

Job Summary

Owning the Quality Management System (QMS), the full-time remote Director of Compliance and Quality is responsible for designing, implementing, and overseeing compliance operations while leading the organization through audits and regulatory inspections.

Key Responsibilities

• Oversee the end-to-end processes of the QMS, ensuring compliance with GMP requirements and effective monitoring through quality metrics and audits
• Track regulatory changes and inspection trends, translating them into actionable readiness strategies for the organization
• Manage the internal audit program and maintain continuous inspection readiness while coordinating responses to audit findings

Required Qualifications

• Bachelor's degree in life sciences, chemistry, engineering, or a related field
• 10+ years of experience in quality assurance or compliance within a regulated laboratory, CDMO, or biopharma environment
• 3+ years of experience leading QA or QC teams
• Deep knowledge of GMP requirements, including 21 CFR Parts 210/211 and data integrity expectations
• Experience with internal audit programs and regulatory inspections, including writing responses to audit findings