Senior GMP QC Compliance Specialist (Remote)

Shift:

Monday through Friday, 8:00AM - 5:00PM

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The Senior QC Compliance Specialist serves as the primary compliance authority embedded within the QC laboratory, ensuring that all analytical and quality control operations supporting mRNA and biologics manufacturing are conducted in full accordance with applicable GxP regulations, internal quality standards, and global regulatory expectations.

This senior-level role acts as a strategic compliance partner to QC laboratory leadership, driving a culture of quality and continuous improvement across all QC functions. The incumbent provides expert guidance on regulatory requirements, leads audit readiness initiatives, oversees quality management system activities, and serves as a mentor and subject matter expert (SME) for QC laboratory staff. The role is critical in bridging day-to-day laboratory operations with the broader site quality framework, ensuring inspection readiness at all times and supporting the integrity of data generated in support of product release, stability, and method lifecycle activities.

1. Key Responsibilities

1.1 GxP Compliance (GMP / GDP / GLP)

• Serve as the site QC SME for GMP, GDP, and GLP regulations as they apply to analytical laboratory operations supporting mRNA and biologics product testing
• Ensure all QC laboratory activities are conducted in compliance with applicable regulatory frameworks including FDA 21 CFR Parts 211, 212, and 600–680; EU GMP Annex 1, 2, 11, and 15; ICH Q2(R2), Q6B, Q10, Q11, and Q14; and WHO/PIC/S guidelines
• Monitor evolving regulatory guidance and industry standards relevant to mRNA and biologics QC (e.g., ICH Q13, emerging mRNA-specific guidance), assess impact on site operations, and drive timely implementation of required changes
• Conduct periodic GxP compliance assessments of QC laboratory areas, equipment, documentation practices, and workflows; identify gaps and lead remediation efforts
• Provide day-to-day GxP compliance guidance to QC analysts, scientists, and supervisors on laboratory practices, documentation standards, and regulatory expectations
• Support GDP compliance for QC reference standards, reagents, and critical materials, ensuring appropriate storage, handling, and traceability

1.2 Regulatory Documentation & Submissions

• Author, review, and approve QC-related sections of regulatory submissions including CTD Module 3 content (analytical procedures, validation reports, specifications, stability data), INDs, BLAs, MAAs, and post-approval variations
• Coordinate with Regulatory Affairs to ensure QC documentation packages are complete, accurate, and aligned with current regulatory expectations prior to submission
• Manage and respond to regulatory agency questions and deficiencies related to QC laboratory data, methods, and compliance practices
• Maintain a current understanding of regulatory submission requirements across major markets (FDA, EMA, PMDA, Health Canada) as they pertain to mRNA and biologics analytical testing
• Ensure QC laboratory records and data packages are maintained in a submission-ready state at all times
• Support preparation of Annual Product Reviews (APRs) and Product Quality Reviews (PQRs) for QC-related sections

1.3 Quality Management System (QMS)

• Act as QC laboratory owner and primary point of contact for the site QMS, ensuring all QC processes are accurately reflected in the quality system and maintained in a current, compliant state
• Oversee the lifecycle management of QC-related controlled documents including Standard Operating Procedures (SOPs), test methods, specifications, protocols, and reports within the electronic document management system (eDMS)
• Drive QMS metrics and Key Performance Indicators (KPIs) for the QC laboratory, including document review cycles, overdue actions, and compliance trends; present findings to QC and site quality leadership
• Lead and facilitate QC participation in Management Review processes, providing data-driven insights on laboratory compliance performance
• Identify systemic quality gaps through trend analysis and proactively implement process improvements to strengthen the QMS
• Collaborate with QA and cross-functional teams to ensure alignment between QC laboratory practices and site-wide quality policies and procedures

1.4 Audit Preparation & Management

• Lead QC laboratory inspection readiness activities on a continuous basis, ensuring the laboratory is prepared for regulatory agency inspections (FDA, EMA, ANSM, MHRA, and