Assoc. Director / Director, QA GLP - United States
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This position is responsible for leading, developing, and maintaining the quality assurance and audit functions for Incyte Good Laboratory Practice (GLP) regulated facilities.
- 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.
- 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%