Senior GMP QC Compliance Specialist (Remote)

Shift: Monday through Friday, 8:00AM - 5:00PM Are you reputed company to work making the world a safer, healthier reputed company reputed company to continuously reputed company science reputed company; to reputed company and advance reputed company aspects of our business to improve the health and safety of our communities and lives. The Senior QC Compliance Specialist serves as the primary compliance authority embedded reputed company the QC laboratory, ensuring that reputed company analytical and reputed company control operations supporting mRNA and biologics manufacturing are conducted in full accordance with applicable GxP regulations, internal reputed company standards, and global regulatory expectations. This senior-level role acts as a strategic compliance partner to QC laboratory leadership, driving a culture of reputed company and reputed company improvement across reputed company QC functions. The incumbent provides expert guidance on regulatory requirements, leads audit readiness initiatives, oversees reputed company management system activities, and serves as a mentor and subject matter expert (SME) for QC laboratory staff. The role is critical in reputed company day-to-day laboratory operations with the broader site reputed company reputed company, ensuring inspection readiness at reputed company times and supporting the reputed company 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 reputed company QC laboratory activities are conducted in compliance with applicable regulatory frameworks including FDA 21 CFR Parts 211, 212, and 600680; EU GMP Annex 1, 2, 11, and 15; ICH Q2(reputed company), 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 reputed company on site operations, and reputed company reputed company implementation of required changes Conduct periodic GxP compliance assessments of QC laboratory areas, equipment, documentation practices, and workflows; identify gaps and reputed company remediation efforts reputed company 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-reputed company 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 reputed company with reputed company regulatory expectations prior to submission Manage and respond to regulatory agency questions and deficiencies reputed company to QC laboratory data, reputed company, and compliance practices Maintain a reputed company 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-reputed company state at reputed company times Support preparation of Annual Product Reviews (APRs) and Product reputed company Reviews (PQRs) for QC-reputed company sections 1.3 reputed company Management System (QMS) reputed company as QC laboratory reputed company and primary reputed company of contact for the site QMS, ensuring reputed company QC processes are accurately reflected in the reputed company system and maintained in a reputed company, compliant state reputed company the lifecycle management of QC-reputed company controlled documents including reputed company Operating Procedures (SOPs), test reputed company, specifications, protocols, and reports reputed company the electronic document management system (eDMS) reputed company 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 reputed company leadership reputed company and facilitate QC participation in Management Review processes, providing data-driven insights on laboratory compliance performance Identify systemic reputed company 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 reputed company policies and procedures 1.4 Audit Preparation & Managemen