- Lead and oversee the Pre-Clinical QA staff and functional Quality Operations within Pre-Clinical QA. Ensure sufficient resources are assigned for Pre-Clinical Quality Assurance Operations.
- Oversee and manage the Pre-Clinical internal and external audit programs to ensure all GxP relevant regulations, guidelines, strategies and standard operating procedures (SOP) are adhered to.
- Contribute to Quality Management System initiatives associated with regulated nonclinical and clinical laboratory functions including designing and implementing appropriate systems and procedures to ensure compliance for document management, auditing, and training.
- Ensure readiness for inspection by regulatory agencies. Monitor and communicate compliance and quality assurance risks to functional and/or quality management.
- Ensure regulated internal bioanalytical laboratories and associated functions (toxicokinetic and pharmacokinetic) meet all GLP requirements for nonclinical and clinical study sample analyses.
- Lead and manage the Pre-Clinical QA external vendor audit program for all outsourced regulated GLP toxicology, nonclinical and clinical bioanalytical, and clinical laboratories. Develop, implement and maintain the external audit schedule. Conduct qualification and routine audits, as needed. Summarize and/or review observations, responses, and audit reports.
- Lead and oversee all audit activities of internal regulated nonclinical and clinical bioanalytical and toxicokinetic studies including in-phase inspections and report/raw data reviews for compliance with protocols, company SOPs, and GLP regulations. Ensure all study related audits are completed and work with business functions to achieve challenging timelines.
- Lead and manage the internal audit program. Develop and maintain internal audit schedule of process and facility audits. Conduct routine audits, as needed. Communicate internal audit schedule with internal business partners. Share observations and continuous improvements with functional managers.
- Provide expertise 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.
- Responsible for preparation, managing and/or participating in regulatory agency inspections including responding to regulatory agency observations requiring corrective action a timely manner.
- Responsible for developing, authoring and maintenance of Pre-Clinical Quality Assurance SOPs, forms, templates and attachments. Review and approve all GLP business function SOPs.
- Ensure GLP training programs are in place for introductory or routine training to the company's employees on a periodic and ongoing basis.
- Lead, manage, mentor and develop direct reports, consultants or contractors.
- Develop, maintain and report quality metrics and share output with Quality and Functional management.
- Identify and propose solutions to known issues and foster a continuous improvement culture
- Be familiar with and assist management of assigned QA budget
- 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 by management.
- Bachelor's degree required, preferably in a scientific discipline.
- 5-10 years' experience in Pharmaceutical or biotechnology environment.
- Minimum 5 years' experience in Quality Assurance in a Pharmaceutical or biotechnology environment with US Food and Drug Administration (FDA) or other regulated environment.
- 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 organizational skills.
- Strong computer skills including knowledge and experience using Microsoft applications, Analyst, Watson, WinNonlin, and document management systems.
- Ability to travel 15-20%.
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Associate Director - Wilmington, United States - InCyte
Description
Overview
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity.
Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.Job Summary (Primary function):
The Associate Director - Director, PreClinical QA provides oversight of regulated laboratory activities and ensures that quality systems are developed and maintained to regulatory standards and Incyte standards.
This position is responsible for leading, developing, and maintaining the quality assurance programs, audit functions and policies for Incyte Pre-Clinical activities including Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) activities.
Essential Functions of the Job (Key responsibilities)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.Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact if you have any questions or concerns or would like to exercise your rights.
