GMP QC Compliance Specialist
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Job Description
Senior QC compliance specialist guiding GMP, audits, QMS, data integrity, and regulatory submissions for Pace’s mRNA and biologics laboratories. Supporting safer, healthier outcomes through scientific laboratory services.
Responsibilities:
- Serve as the primary compliance authority and QC subject matter expert for mRNA and biologics laboratory operations
- Ensure analytical and quality control activities comply with GxP regulations, internal quality standards, and global regulatory expectations
- Monitor regulatory developments, assess operational impact, and implement required changes
- Conduct GxP compliance assessments and lead remediation efforts
- Author, review, and approve QC sections of regulatory submissions, including CTD Module 3 content, INDs, BLAs, MAAs, and post-approval variations
- Coordinate QC documentation with Regulatory Affairs and respond to regulatory questions and deficiencies
- Own and maintain QC processes within the site quality management system
- Oversee controlled documents, SOPs, methods, specifications, protocols, and reports in the eDMS
- Track QC compliance metrics and KPIs and present findings to quality leadership
- Lead QC inspection readiness, audits, self-inspections, audit responses, CAPAs, and follow-up activities
- Design and maintain GxP training and competency programs for QC personnel
- Lead QC change control, deviation, non-conformance, root-cause analysis, and CAPA activities
- Champion data integrity and oversee assessments, audit trails, raw data verification, and system controls
- Ensure LIMS, CDS, ELN, and instrument software comply with applicable validation and data integrity requirements
- Manage QC supplier qualification, monitoring, audits, Certificates of Analysis, and approved supplier records
- Mentor QC staff and collaborate with QC, QA, Regulatory Affairs, HR, Procurement, and Supply Chain teams
Requirements:
- Minimum 5 years of progressive experience in pharmaceutical or biopharmaceutical QC, Quality Assurance, or a combined QC/QA compliance role
- Experience supporting QC laboratory operations in a GMP-regulated biologics or mRNA environment
- Proven experience managing regulatory inspections and internal audits within a QC laboratory setting
- Hands-on experience with deviation management, CAPA systems, change control, deviation 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
- In-depth knowledge of FDA 21 CFR Parts 211 and 600–680
- Knowledge of EU GMP Guidelines Annexes 1, 2, 11, and 15
- Knowledge of ICH Q2(R2), Q6B, Q10, Q11, and Q14
- Knowledge of PIC/S guidelines
- Strong understanding of data integrity principles and regulatory expectations
- Knowledge of GMP, GDP, and GLP requirements for analytical laboratory operations
- Experience with mRNA and biologics analytical testing, product release, stability, and method lifecycle activities
- Experience with LIMS, CDS, ELN, electronic document management systems, and instrument software
- Knowledge of 21 CFR Part 11 and EU Annex 11 requirements
- Experience with audit trail reviews, raw data verification, and system access controls
- Experience with structured problem-solving methods such as Ishikawa, 5-Why, and Fault Tree Analysis
Benefits:
- Competitive salaries
- Medical insurance
- Dental insurance
- Vision insurance
- 401K retirement savings plan
- Employer match is 100% vested immediately
- Life insurance
- Disability benefits
- Voluntary benefits
- Paid time off for holidays
- Paid sick days
- Paid vacation days
- HSA
- Wellness program
- Flexible spending accounts
- Tuition reimbursement
- Employee Assistance program
- Parental leave
- Optional legal coverage
- ID theft protection
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