Job Summary (Primary function)
The Manager/Sr. Manager, Pre-Clinical QA provides oversight of regulated laboratory activities and ensures that quality systems are developed and maintained to regulatory and Incyte standards. This position is responsible for leading, developing, and maintaining the quality assurance programs, conducting and managing the quality assurance audit functions for Incyte Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) regulated activities.
- Conducting internal and external audits to ensure all GLP/cGLP relevant regulations, guidelines, strategies and standard operating procedures (SOP) are adhered to.
- Perform Preclinical QA qualification and routine audits for all outsourced regulated GLP toxicology, nonclinical and clinical bioanalytical, and clinical laboratories. Generate audit agendas and reports to summarize findings. Evaluate audit responses, follow up on responses and ensure audit closure
- Conduct external vendor audits for clinical sample analyses to ensure compliance with GLP, GCP, and CLIA/CAP, as applicable.
- Ensure regulated internal bioanalytical laboratories and associated functions (toxicokinetic and pharmacokinetic) meet all GLP requirements for nonclinical and clinical study sample analyses.
- Conduct 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. Ensure business timelines are met.
- Summarize and/or review audit observations, responses and generate audit reports. Follow up on audit findings and report any non-compliances to functional and quality management.
- Use Quality Management systems for reporting and tracking QA activities.
- Assist with Quality Assurance initiatives and projects including document management, SOP writing and review, training, and CAPA.
- Provide support and guidance in interpreting the applicable GLP regulations and liaise with the business functions to resolve any quality and compliance issues on an ongoing basis for functions supporting GLP studies or clinical laboratories.
- Assist with development and implementation of Preclinical Quality Assurance GLP SOPs, forms, templates and attachments.
- Assist with GLP training program and provide training as needed to company employees.
- Assist with regulatory agency inspections and inspection readiness.
- Assist with archival of QA documents in accordance with federal regulations and ensure all data and documents associated with internal GLP activities are archived in accordance with federal regulations.
- Keep current on governmental regulatory requirements related to Good Laboratory Practice for Nonclinical Laboratory Studies, Title 21 CFR §58.
- Other duties as assigned
Qualifications (Minimal acceptable level of education, work experience, and competency)
- 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.
- Strong computer skills including knowledge and experience using Microsoft applications, Analyst, Watson, WinNonlin, and document management systems.
- Ability to travel 30%.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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