Senior GMP QC Compliance Specialist

Pace® Labs

Senior QC Compliance Specialist ensuring GxP compliance in QC laboratory supporting mRNA and biologics. Acting as strategic partner and driving quality improvement initiatives.

Posted 7/9/2026full-timeRemote • 🇵🇷 Puerto RicoSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality ControlQuality AssuranceRegulatory ComplianceDeviation ManagementCAPA SystemsChange ControlSOP AuthoringValidation ProtocolsData Integrity PrinciplesRegulatory Frameworks

Soft Skills

MentoringLeadershipStrategic PartnershipContinuous Improvement