Senior GMP QC Compliance Specialist (Remote)

Shift:

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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 other competent authorities) and internal/external audits at all times
• Serve as the primary QC laboratory representative and SME during regulatory inspections and audits; coordinate QC staff participation, manage document requests, and facilitate inspector interactions
• Prepare and maintain QC-specific inspection readiness materials including mock inspection programs, audit binders, facility tour routes, and SME briefing documents
• Lead and conduct internal self-inspections of QC laboratory areas, systems, and documentation; document findings and drive timely closure of identified gaps
• Manage QC laboratory responses to audit observations and regulatory findings; author CAPA plans, track implementation, and verify effectiveness
• Coordinate with QA and site leadership on pre-inspection preparation activities and post-inspection follow-up commitments

1.5 Training & Competency

• Design, implement, and maintain a comprehensive GxP training program for QC laboratory personnel, encompassing regulatory requirements, SOPs, data integrity, laboratory practices, and role-specific competencies
• Develop and deliver training curricula tailored to the unique compliance requirements of mRNA and biologics QC operations, including specialized topics such as aseptic technique, cold chain handling, and advanced analytical technologies
• Establish and oversee a structured competency assessment framework for QC analysts and scientists, ensuring documented evidence of qualification for all critical laboratory tasks
• Monitor training compliance metrics across the QC organization; identify gaps and implement corrective actions to maintain full training currency
• Mentor junior and mid-level QC staff on GxP compliance principles, documentation best practices, and quality culture; act as a role model for compliance excellence
• Collaborate with QA Training and HR to ensure QC training records are maintained in the Learning Management System (LMS) and are audit-ready

1.6 Change Management & Deviation Handling

• Serve as the QC laboratory lead for change control, overseeing the initiation, assessment, approval, and implementation of changes impacting QC methods, equipment, reagents, specifications, and laboratory systems
• Conduct and review GxP impact assessments for proposed changes, ensuring regulatory implications are thoroughly evaluated and appropriate validation, verification, or notification activities are completed prior to implementation
• Lead the QC laboratory deviation and non-conformance management program; ensure timely initiation, thorough investigation, accurate root cause analysis, and robust CAPA development for all laboratory events
• Apply structured problem-solving methodologies (e.g., Ishikawa, 5-Why, Fault Tree Analysis) to complex or recurring deviations; identify systemic issues and drive sustainable corrective actions
• Review and approve deviation reports, CAPA plans, and effectiveness checks for QC laboratory events; ensure documentation meets regulatory standards
• Track and trend deviations, OOS/OOT results, and change controls to identify patterns and proactively address emerging compliance risks; report findings to QC and site quality leadership

1.7 Data Integrity & ALCOA+

• Champion a robust data integrity culture within the QC laboratory, ensuring all data generated in support of product testing, release, and stability is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA+)
• Conduct periodic data integrity assessments and audits of QC laboratory systems, instruments, and records (paper and electronic), including audit trail reviews, raw data verification, and system access controls
• Ensure QC computerized systems (LIMS, CDS, ELN, instrument software) are validated and operated in compliance with 21 CFR Part 11, EU Annex 11, and applicable data integrity guidance (MHRA, FDA, PIC/S)
• Develop and maintain QC-specific data integrity SOPs, risk assessments, and monitoring programs
• Investigate data integrity concerns or anomalies; lead root cause analysis and implement corrective actions; escalate significant findings to QC and QA leadership as appropriate
• Provide data integrity training and awareness programs to QC staff, reinforcing expectations and consequences of non-compliance

1.8 Supplier & Vendor Compliance

• Manage the QC laboratory supplier qualification and monitoring program, ensuring all critical reagents, reference standards, consumables, and service providers meet defined quality and compliance requirements
• Conduct and/or coordinate supplier audits and assessments for QC-critical vendors; review audit reports and manage follow-up on identified deficiencies
• Evaluate and approve Certificates of Analysis (CoA), qualification data, and technical documentation from suppliers of QC materials; ensure materials meet established specifications prior to use
• Maintain the QC approved supplier list and associated qualification records; ensure timely re-qualification and periodic review of critical suppliers
• Collaborate with Procurement, QA, and Supply Chain to manage supplier changes, assess regulatory impact, and ensure continuity of supply for critical QC materials
• Monitor supplier performance metrics and escalate quality concerns; support supplier development activities where required

2. Required Qualifications

Experience

• Minimum 5 years of progressive experience in pharmaceutical or biopharmaceutical QC, Quality Assurance, or a combined QC/QA compliance role
• Demonstrated experience supporting QC laboratory operations in a GMP-regulated biologics or mRNA environment
• Proven track record of managing regulatory inspections (FDA, EMA, or equivalent) and internal audits within a QC laboratory setting
• Hands-on experience with deviation management, CAPA systems, change control, Deviation, lan investigations, and quality management systems in a regulated pharmaceutical environment
• Experience authoring and reviewing GxP-compliant documentation including SOPs, validation protocols/reports, and regulatory submission content

Regulatory & Technical Knowledge

• In-depth knowledge of applicable regulatory frameworks: FDA 21 CFR Parts 211, 600–680; EU GMP Guidelines (Annex 1, 2, 11, 15); ICH Q2(R2), Q6B, Q10, Q11, Q14; PIC/S
• Strong understanding of data integrity principles and regulatory

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Benefits
When you join Pace®, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

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