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Christine Brotherton

@christinebrotherton

I lead GCP-regulated clinical bioanalytical studies, strengthening audit readiness, CAPA effectiveness, and regulatory compliance.

United States

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What I'm looking for

I'm looking for a clinical research or quality-focused role where I can lead GCP compliance, audit readiness, CAPA management, and cross-functional quality oversight in regulated studies.

At Labcorp, I served as a Principal Investigator and de facto quality lead for Phase I–IV PK, ADA, and NAb immunoassay programs, providing GCP oversight across study lifecycles.

I investigate deviations, develop and assess CAPAs, analyze and report data, and communicate quality risks, timelines, and scientific deliverables with clients and functional leads. I also supported an electronic data-capture eNotebook rollout as a local SME and trained staff on GCP-compliant electronic data practices.

My foundation includes GMP pharmaceutical manufacturing at Tolmar and QMS, audit, and laboratory-supervision work with the Virginia Department of Agriculture. I bring experience across GCP, GMP, GLP, FDA requirements, ICH M10, data integrity, method validation, and regulated laboratory operations.

Experience

Work history, roles, and key accomplishments

Associate Lead Scientist (Principal Investigator)

Labcorp Inc.

Jun 2019 - Oct 2025 (6 years 4 months)

Senior scientist and de facto quality lead for GCP-regulated clinical bioanalytical studies, serving as Principal Investigator for Phase I-IV PK, ADA, and NAb immunoassay programs. Provided independent GCP quality oversight and conducted audit readiness activities.

GCP ICH M10 GLP FDA Regulations Audit CAPA Veeva Vault QMS Watson LIMS Excel ALCOA+ Standards EDC ENotebook 21 CFR Part 11 method validation Reagent Management Mentorship

Microbiologist Supervisor

Virginia Department of Agriculture

Feb 2018 - Feb 2019 (1 year)

Oversaw QMS implementation, personnel management, audit coordination, and regulatory compliance for a state veterinary diagnostic laboratory. Authored SOPs, facilitated audits, and managed LIMS data.

QMS ISO Standards Audit CAPA Validation Studies LIMS EVA Training Personnel Management

Microbiologist

Tolmar, Inc.

Sep 2013 - Feb 2018 (4 years 5 months)

GMP compliance and environmental monitoring oversight for aseptic pharmaceutical manufacturing facilities. Conducted batch record reviews, environmental monitoring, and incident investigations.

GMP ISO 13485 21 CFR 820 Environmental Monitoring Root Cause Analysis LIMS Change Control Aseptic Technique Training

Lab Assistant

Summit Pathology

Nov 2010 - Aug 2013 (2 years 9 months)

Co-authored and edited Standard Operating Procedures to maintain CLIA certification and attain CAP certification for cytology department. Conducted training and processed specimens.

SOP Development CLIA CAP Training Specimen Processing Inventory Management