Compliance Manager, Pharma cGMP & QMS
Overview
You own compliance for pharmaceutical operations at Mark Cuban Cost Plus Drug Company, a mission-driven organization expanding access to affordable medicines. You coordinate document control, investigations, and audit readiness across manufacturing, laboratory, and distribution. You work directly with quality assurance, regulatory, and operations teams to maintain FDA cGMP compliance. This role offers the chance to shape a high-impact compliance program from the ground up, with direct influence on patient safety.
What You'll Do6
- 1Coordinate the review, revision, and issuance of SOPs and master batch records to ensure accuracy and compliance.
- 2Investigate manufacturing deviations, non-conformances, and OOS laboratory results to identify root causes.
- 3Monitor progress of CAPAs and change controls to drive timely closure and prevent recurrence.
- 4Conduct internal facility inspections to identify compliance gaps and verify adherence to cGMP.
- 5Audit executed batch records, logbooks, and sterilization records to ensure data integrity before product release.
- 6Maintain audit readiness by organizing documentation and preparing for regulatory inspections.
Requirements6
- 1Bachelor's degree in Chemistry, Microbiology, Biology, Pharmacy, or a related scientific field.
- 22-4 years in an QA/QC or compliance role within an FDA-regulated pharmaceutical industry.
- 3Solid understanding of cGMP regulations (21 CFR Parts 210/211) or USP compounding guidelines.
- 4Proficiency with electronic Quality Management Systems (eQMS) and standard office software.
- 5Experience with cleanroom monitoring or aseptic processing compliance (preferred).
- 6ASQ Certified Quality Auditor or similar certification (preferred).
Salary Insight
$95 - $105k per year
Location
Required Skills
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