Senior GMP Compliance Specialist

Job Summary

To ensure compliance with GxP regulations in analytical operations, the full-time Senior GMP QC Compliance Specialist will serve as the primary compliance authority within the QC laboratory, providing expert guidance, leading audit readiness initiatives, and mentoring staff in a remote work environment.

Key Responsibilities

• Serve as the site QC subject matter expert for GMP, GDP, and GLP regulations, ensuring compliance in laboratory operations
• Author and review QC-related sections of regulatory submissions, ensuring accuracy and alignment with regulatory expectations
• Lead inspection readiness activities and manage responses to audit observations and regulatory findings

Required Qualifications

• Minimum 5 years of experience in pharmaceutical or biopharmaceutical QC or QA compliance roles
• Demonstrated experience in GMP-regulated biologics or mRNA environments
• Proven track record in managing regulatory inspections and internal audits
• Hands-on experience with deviation management and quality management systems
• In-depth knowledge of FDA and EU GMP regulatory frameworks