QC Manager

Job Description: QC Manager - Biomarker and Biologics LaboratoryJob Title: Quality Control (QC) Manager Department: Biomarker & Biologics Location: Exton, PA (Onsite) Position Summary The QC Manager is responsible for oversight of the Quality Control function supporting compliant biologics and biomarker testing performed using ligand-binding assay (LBA) platforms and other immunoassay. This role ensures that study data, assay performance, regulated documentation, and reporting meet GLP, data integrity, and client requirements. The QC Manager leads a team of QC reviewers responsible for data verification, review of assay outputs, documentation accuracy, and compliance across all GLP bioanalytical studies. Key ResponsibilitiesOversight for Bioanalytical LBA Studies Ensure QC activities adhere to GLP regulations (FDA 21 CFR Part 58, OECD GLP) and bioanalytical industry expectations (FDA/EMA BMV guidance). Assign QC reviewer to the studies and maintain QC review capacity to ensure timely delivery of QC'ed data/reports/deliverable with high quality. Oversee QC review of study data and study integrity. Provide guidance and training to QC team to establish/optimize sustainable review process and improve the effectiveness and accuracy of QC review. Data Review & Study Support 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. Management 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. Quality Systems & Documentation 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. Continuous Improvement & Laboratory Support 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. QualificationsEducation Bachelor's or Master's in Biology, Biochemistry, Immunology, Biotechnology, or related field. Experience 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. Skills & Competencies Strong understanding of GLP and FDA/EMA bioanalytical method validation (BMV) guidance. Expertise in immunoassay data review: plate performance, curve fitting models, QC trends, and analytical run acceptance. Proficiency with relevant software (SoftMax Pro, E-WorkBook, Watson LIMS, ELN/LIMS systems). Strong communication skills for interactions with Study Directors, analysts, QA, and clients. Excellent attention to detail and the ability to identify subtle data inconsistencies. Ability to manage multiple concurrent GLP studies under tight deadlines. Key Personal Attributes 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.

Created: 2026-03-10