Technical Transition Manager leading the transition from outsourced IT to hybrid delivery at Barnet Council. Driving technical change and ensuring security and value for money.
About the role
- QC Manager overseeing quality control for biologics and biomarker testing in a laboratory. Leading compliance with GLP regulations and managing a team of QC reviewers in Exton, PA.
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.
- 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.
- 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).
Requirements
- 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.
- 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).
Benefits
- Health insurance
- Paid time off
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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