GMP QC Compliance Specialist – Remote

About the role

The Senior QC Compliance Specialist is the primary compliance authority embedded within the QC laboratory, ensuring that all analytical and quality control activities for mRNA and biologics manufacturing meet GxP regulations and internal standards. This remote position supports the integrity of data used for product release, stability, and method lifecycle activities.

Key responsibilities

• Serve as the site QC subject‑matter expert for GMP, GDP, and GLP regulations applicable to analytical laboratory operations.
• Ensure compliance with FDA 21 CFR Parts 211, 212, 600‑680; EU GMP Annexes 1, 2, 11, 15; ICH Q2(R2), Q6B, Q10, Q11, Q14; and WHO/PIC/S guidelines.
• Monitor evolving regulatory guidance (e.g., ICH Q13, emerging mRNA‑specific guidance) and drive implementation of required changes.
• Conduct periodic GxP compliance assessments, identify gaps, and lead remediation efforts.
• Provide day‑to‑day GxP guidance to QC analysts, scientists, and supervisors on laboratory practices and documentation.
• Support GDP compliance for reference standards, reagents, and critical materials.
• Author, review, and approve QC sections of regulatory submissions (CTD Module 3, INDs, BLAs, MAAs, post‑approval variations).
• Coordinate with Regulatory Affairs to ensure completeness and accuracy of QC documentation packages.
• Manage agency queries and deficiencies related to QC data, methods, and compliance.

Required profile

• Senior‑level experience in QC compliance within a GMP‑regulated environment, preferably in mRNA or biologics manufacturing.
• Deep knowledge of GxP regulations and ability to act as a strategic compliance partner to laboratory leadership.
• Proven track record of leading audit readiness initiatives and quality management system activities.
• Strong communication skills to mentor laboratory staff and serve as a subject‑matter expert.

Required skills

• GMP, GDP, GLP regulatory knowledge.
• FDA 21 CFR Parts 211, 212, 600‑680.
• EU GMP Annexes 1, 2, 11, 15.
• ICH guidelines Q2(R2), Q6B, Q10, Q11, Q14 (and emerging Q13).
• WHO/PIC/S guidelines.
• Regulatory submission preparation (CTD Module 3, IND, BLA, MAA, post‑approval variations).
• Audit readiness and quality management system implementation.