Pace® Labs
1001 - 5000 employees
Environmental Consulting • Pharma/Biopharmaceutical • Medical Device
Pace® Labs is a nationwide network of laboratories and professional services that provides analytical and environmental testing, life‑sciences CDMO/CRO and central laboratory services, building‑science and laboratory support, and emergency response for contamination and outbreak events. The company delivers environmental sampling and testing (air, water, soil, PFAS, Legionella, VOCs, metals, radiochemistry, etc. ), GMP analytical testing and formulation/clinical manufacturing support for pharma and biopharma, medical device testing and regulatory/compliance consulting, plus instrument, cleanroom and facility services to regulated industries.
Senior GMP QC Compliance Specialist
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Pace® Labs
1001 - 5000 employees
Environmental Consulting • Pharma/Biopharmaceutical • Medical Device
Pace® Labs is a nationwide network of laboratories and professional services that provides analytical and environmental testing, life‑sciences CDMO/CRO and central laboratory services, building‑science and laboratory support, and emergency response for contamination and outbreak events. The company delivers environmental sampling and testing (air, water, soil, PFAS, Legionella, VOCs, metals, radiochemistry, etc. ), GMP analytical testing and formulation/clinical manufacturing support for pharma and biopharma, medical device testing and regulatory/compliance consulting, plus instrument, cleanroom and facility services to regulated industries.
📋 Description
• Serve 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. • Act as a strategic compliance partner to QC laboratory leadership, driving a culture of quality and continuous improvement across all QC functions. • Provide expert guidance on regulatory requirements, lead audit readiness initiatives, oversee quality management system activities, and serve as a mentor and subject matter expert (SME) for QC laboratory staff. • Ensure inspection readiness at all times and support the integrity of data generated in support of product release, stability, and method lifecycle activities.
🎯 Requirements
• 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, 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 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
🏖️ Benefits
• 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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