Senior Manager

4 weeks ago

Wilmington, Delaware, United States Incyte Full time

Job Summary

The Senior Manager - PreClinical QA Lead at Incyte is responsible for overseeing regulated laboratory activities and ensuring quality systems are developed and maintained to regulatory and Incyte standards. This position leads, develops, and maintains quality assurance programs, conducts and manages quality assurance audit functions for Incyte Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) regulated activities.

Key Responsibilities

  • Conducting internal and external audits to ensure all GLP/cGLP relevant regulations, guidelines, strategies, and standard operating procedures (SOP) are adhered to.
  • Performing Preclinical QA qualification and routine audits for all outsourced regulated GLP toxicology, nonclinical, and clinical bioanalytical, and clinical laboratories.
  • Generating audit agendas and reports to summarize findings, evaluating audit responses, and following up on responses to ensure audit closure.
  • Conducting external vendor audits for clinical sample analyses to ensure compliance with GLP, GCP, and CLIA/CAP, as applicable.
  • Ensuring regulated internal bioanalytical laboratories and associated functions (toxicokinetic and pharmacokinetic) meet all GLP requirements for nonclinical and clinical study sample analyses.
  • Conducting internal audits of regulated nonclinical and clinical bioanalytical and toxicokinetic studies, including in-phase inspections, report/raw data reviews, and process/facility audits for compliance with protocols, company SOPs, and GLP regulations.
  • Ensuring business timelines are met, summarizing and/or reviewing audit observations, responses, and generating audit reports, and following up on audit findings and reporting any non-compliances to functional and quality management.
  • Using Quality Management systems for reporting and tracking QA activities, assisting with Quality Assurance initiatives and projects, including document management, SOP writing and review, training, and CAPA.
  • Providing support and guidance in interpreting the applicable GLP regulations and liaising with the business functions to resolve any quality and compliance issues on an ongoing basis for functions supporting GLP studies or clinical laboratories.
  • Assisting with development and implementation of Preclinical Quality Assurance GLP SOPs, forms, templates, and attachments, and assisting with GLP training program and providing training as needed to company employees.
  • Assisting with regulatory agency inspections and inspection readiness, and assisting with archival of QA documents in accordance with federal regulations and ensuring all data and documents associated with internal GLP activities are archived in accordance with federal regulations.

Qualifications

  • Bachelor's degree required, preferably in a scientific discipline.
  • 5-10 years' experience in Pharmaceutical or biotechnology environment.
  • Minimum of 1-2 years lead auditor experience performing GLP compliance audits of vendors, and/or internal systems/process/facility.
  • Understanding of GLP regulations and experience with bioanalytical testing of small and large molecule drug substance in regulated environment is preferred.
  • Ability to manage and prioritize projects under tight deadlines, strong written, oral communication, interpersonal, and organization skills, and strong computer skills including knowledge and experience using Microsoft applications, Analyst, Watson, WinNonlin, and document management systems.
  • Ability to travel 30%.

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