QC Manager

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., Soft Max 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 (Soft Max Pro, E-Work Book, 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.