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Assoc. Director / Director, QA GLP Wilmington United States,  


Posted on : 07 May 2017

Project Description

  This position is responsible for leading, developing, and maintaining the quality assurance and audit functions for Incyte Good Laboratory Practice (GLP) regulated facilities. Responsibilities:  Ensure Incyte Good Laboratory Practice (GLP) bioanalytical, toxicokinetic and pharmacokinetic laboratories and associated functions meet all GLP requirements for nonclinical and clinical study sample analyses. Ensure external GLP facilities and associated functions meet all GLP requirements for nonclinical and clinical sample analyses, if applicable. Assist in designing and implementing quality systems and maintain appropriate systems and procedures to ensure GLP compliance including document control, auditing, and training. Conduct internal audits and manage internal audit program to assure GLP relevant regulations, guidelines, strategies and standard operating procedures (SOP) are adhered to. Ensure readiness for inspection by regulatory agencies. Inform upper management of compliance or quality risks and concerns. Develop and manage the GLP bioanalytical (small and large molecule) and toxicology contract research organization (CRO) audit program. Perform qualification/maintenance audits of all GLP facilities.  Develop implement and maintain the contractor audit/visit schedule.  Generate audit agendas and reports to summarize findings.  Evaluate audit responses and follow up on responses and audit closure. Implement procedures for inclusion of controlled documents into regulatory submissions. Coordinate preparation for and manage regulatory agency inspections.  Formally respond to regulatory agency observations requiring corrective action a timely manner. Develop, author and implement Quality Assurance GLP SOPs, forms, templates and attachments.  Perform or manage QA review and approval of all GLP SOPs. Develop GLP training programs and provide introduction and current training to the company’s employees on a periodic and ongoing basis. Review and approve bioanalytical/toxicokinetic reports for compliance with GLP and company SOPs. Manage and coordinate Quality Assurance consultant visits and audits and provide corrective/preventive actions and improve quality systems where necessary. Liaise between the company, Incyte toxicologists and Quality Assurance and/or study directors at GLP contractor facilities.  Satisfactorily resolve quality and compliance issues with contract facilities on an ongoing basis. Provide support to Regulatory Affairs with regard to FDA submission activities. Keep current on governmental regulatory requirements related to Good Laboratory Practice For Nonclinical Laboratory Studies, Title 21 CFR §58 and the Organization of Economic Co-operation with Development (OECD) Principles of Good Laboratory Practice and Compliance Monitoring. Ensure all data and documents associated with internal GLP activities are archived in accordance with federal regulations. Use databases to track, trend, report QA activities and identify improvements. Other duties as assigned by management. Minimum Requirements:  Bachelor’s degree required, preferably in a scientific discipline. 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. Knowledge of US, European (EU), ICH Regulations, Guidelines and requirements.  Knowledge of GLP requirements for the testing of large and small molecule drug substance in regulated nonclinical studies. Thorough understanding of document control procedures and practices in the pharmaceutical industry. Strong written, oral communication, interpersonal, and organization skills Strong computer skills including knowledge and experience with Microsoft applications Ability to travel 15-20%

Locations

Wilmington DE

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