QC Manager

Lead QC review of validation protocols, sample analysis plans, plate layouts, run sheets, and controlled forms.

Ensure GLP sample analysis is performed according to validated methods, study protocols, and SOPs.

Confirm integrity of electronic data (ELN/LIMS, plate reader software, instruments outputs).

Review bioanalytical reports, validation summaries, run acceptance decisions, and performance qualification documentation.

Collaborate with PI/RS, Bioanalytical Scientists, and QA to address errors, deviations.

Support on the data and documentation review for the CAP/CLIA assays handled by biomarker and biologics team.

Lead, train, and mentor QC reviewers and specialists supporting the workflows.

Allocate workloads to meet numerous parallel GLP validation and sample-analysis timelines.

Maintain a highly organized QC workflow to support fast-turnaround studies and late-stage clinical sample testing.

Build competency in reviewing complex LBA datasets, including multiplex assays, bridging assays, ADA/NAb workflows, biomarker assays and pharmacokinetics (PK) immunoassays.

Oversee controlled documents including QC training documentation, controlled forms, templates, QC checklists and relevant QC documents.

Support and review deviations, investigations and reports/reports templates.

Ensure reviewed study documents meeting the GLP compliance and follows SOPs.

Establish QC metrics (review cycle time, error rates, audit observations) and drive continuous process improvements.

Provide feedback on process gaps, such as data integrity gaps in LIMS or instrument workflows (e.g., SoftMax Pro, MSD Discovery Workbench, SIMOA software).

Implement improvements in plate-level documentation, run acceptance criteria, and audit trails.

Support inspection readiness for FDA, EMA, and client audits.

Drive harmonization and standardization of QC workflows across LBA platforms.

Bachelor’s or Master’s in Biology, Biochemistry, Immunology, Biotechnology, or related field.

5–10+ years of experience in regulated bioanalytical laboratories.

Strong background in GLP compliance and regulated bioanalysis.

Minimum 2–5 years of supervisory or leadership experience in QC, QA, or bioanalytical data review roles.

High integrity, strong quality mindset, and firm understanding of regulatory expectations.

Calm, thorough, and effective in fast-paced study timelines and audit environments.

Collaborative, supportive leadership style with a focus on training and developing reviewers.

Strong problem-solving approach with focus on risk mitigation and process excellence.