Sr. Manager, QA GLP

Incyte Corporation - Wilmington, DE (30+ days ago)3.8


Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development, and commercialization of proprietary therapeutics, primarily for oncology. Our first commercial product, Jakafi®, is approved in the U.S. for patients with intermediate or high-risk myelofibrosis and for patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. We have a diverse and growing portfolio of product candidates, including both small and large molecules.

Our Quality Assurance group is looking for a Manager/Sr. Manager, QA GLP. This position is responsible for conducting and managing the quality assurance and audit functions for Incyte Good Laboratory Practice (GLP) internal and external regulated activities.

Responsibilities:
Quality Assurance auditor responsible for ensuring Incyte Good Laboratory Practice (GLP) bioanalytical, toxicokinetic and pharmacokinetic laboratories and associated functions meet all GLP requirements for nonclinical and clinical study sample analyses.
Conduct internal audits according to internal audit program to assure GLP relevant regulations, guidelines, strategies and standard operating procedures (SOP) are adhered to.
Conduct external GLP bioanalytical (small and large molecule) and toxicology contract research organization (CRO) audits. Perform qualification/maintenance audits of all GLP facilities. Generate audit agendas and reports to summarize findings. Evaluate audit responses and follow up on responses and audit closure.
Conduct external vendor audits for clinical sample analyses to ensure compliance with GLP, GCP, and CLIA/CAP, as applicable.
Review and approve bioanalytical/toxicokinetic reports for compliance with GLP and company SOPs.
Review and approve Computer System Validation (CSV) Validation Plans and Reports. Liaise with the CSV QA team and GLP team on 21 CFR Part 11 compliant laboratory systems and deliverables.
Assist with development and implementation of Quality Assurance GLP SOPs, forms, templates and attachments.
Assist with GLP training program and provide training as needed to company employees.
Provide support or liaise with GLP study personnel including Incyte staff and external study directors on quality, compliance and timelines for nonclinical studies.
Assist with regulatory agency inspections and inspection readiness.
Assist with archival of QA documents in accordance with federal regulations.
Use databases to track, trend, report QA activities and identify improvements.
Assist with QA related projects including document management, training, and CAPA.
Act as backup to Associate Director GLP QA, as needed.
Other duties as assigned by management.

Qualifications:
Bachelors degree in scientific/life-sciences or related field
Minimum 5 – 7 years in Quality Assurance in a Pharmaceutical or biotechnology environment with United States Food and Drug Administration (FDA) or other regulatory agency inspection experience.
Thorough understanding of GLP regulations and experience with bioanalytical testing of small and large molecule drug substance in regulated nonclinical studies is preferred.
Experience with CLIA/CAP regulations and Clinical laboratory audits is preferred.
Experience with 21 CFR Part 11 regulations and guidelines is preferred.
Ability to manage and prioritize projects under tight deadlines.
Strong written, oral communication, interpersonal, and organization skills.