Job Description: QC Manager – Biomarker and Biologics Laboratory
Job 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 Responsibilities
Oversight 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.
Qualifications
Education
- 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.
