Quality Control Lead

Quality Control (QC) Manager – GLP & Data IntegrityThe OpportunityWe’re building a new standard in endotoxin detection using Limulus Amebocyte Lysate (LAL) capable of identifying trace, potentially lethal contamination.That only matters if the data holds up.We’re hiring a QC Manager to own:Data integrityGLP alignmentDocumentation and audit readinessThis is the person who ensures everything we produce is:Accurate. Reproducible. Defensible.From day one.What You’ll Be Responsible ForYou are the backbone of credibility across the entire program.Quality Systems & StandardsEstablish and maintain GLP-aligned QC systemsBuild SOPs, documentation frameworks, and review processesEnsure all scientific work meets regulatory expectationsData Integrity & ReviewReview experimental data across:Upstream (cell culture, bioprocessing)Downstream (RUL extraction, assays, analytical testing)Identify inconsistencies, gaps, or risks before they become issuesEnforce high standards for accuracy, traceability, and reproducibilityAudit & Compliance ReadinessPrepare systems and documentation for regulatory inspectionEnsure all processes are audit-ready at all timesSupport validation activities and submission preparationCross-Functional OversightWork closely with:Scientific Director (regulatory alignment)Upstream & Downstream leads (process + data quality)Act as the independent check—not just a box-tickerProcess ImprovementIdentify where quality breaks down and fix itImprove workflows to reduce errors and increase consistencyBuild scalable systems as the team growsWhat “Good” Looks Like in 6–12 MonthsClear, structured QC systems embedded across all workflowsAll data is clean, traceable, and reproducibleSOPs in place and consistently followed across teamsNo surprises when it comes to audits or regulatory reviewScientists respect QC (they don’t always love it—but they trust it)Must-Haves (Non-Negotiable)Strong experience in Quality Control within biotech/pharma/diagnosticsDeep understanding of GLP and regulatory frameworksProven track record of data review and documentation oversightExperience building or improving QC systems and processesHigh attention to detail without losing sight of the bigger pictureNice-to-Haves (But Valuable)Experience with endotoxin, LAL, or assay-based productsExposure to early-stage or scaling environmentsExperience supporting regulatory submissions or auditsFamiliarity with analytical methods (ELISA, qPCR, etc.)What Will Not WorkThis role fails quietly if you get it wrong:“Paperwork-first” QC profiles with no understanding of the sciencePeople who slow everything down without improving qualityCandidates who avoid pushing back on scientistsAnyone who treats QC as admin, not a control functionWho Thrives HereYou are detail-obsessed, but not bureaucraticYou can challenge scientists without creating frictionYou care about getting it right, not just getting it doneYou build systems that scale, not ones that break under pressure