at Incyte Corporation in Wilmington, Delaware, United States
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.
The Sr. Manager / Associate Director, Clinical Quality Assurance provides global audit support and GCP oversight of Clinical Operations teams to the Head of QA-GCP. The Associate Director executes and manages QA-GCP audits and GCP guidance and advice across assigned departments within the Development Trials group.
Essential Functions of the Job (Key responsibilities)
Plan, schedule and conduct audits of Clinical Investigator Sites, CROs, and Clinical submission documents.
Assist in development and review of responses and corrective actions related to audit activities and reports.
Actively manage GCP advice and support to Incyte Development Operations and other relevant Clinical functions.
Stay abreast of clinical trial requirements, FDA, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the US/EU and other regions, as appropriate.
Assist in the review and revision of Clinical Development and QA SOPs.
Conduct GCP training for Incyte staff.
Alert QA GCP Management of internal and external GCP compliance and clinical trial issues in a timely manner.
Assist in risk identification and suggest mitigation plans related to assigned projects.
Become thoroughly familiar with assigned Incyte compounds and protocols.
Provide support for regulatory authority inspections including conducting pre-inspection audits of sites, CROs and processes.
Assist with the management of QA consultants performing audits on behalf of Incyte.
Qualifications (Minimal acceptable level of education, work experience, and competency)
5-10 years' experience in a pharmaceutical or bio-pharmaceutical company with a minimum of 5 years' experience in a GCP QA role conducting audits of CROs and investigator sites.
Strong written and oral communication skills.
Prior Regulatory inspection experience preferred.
Ability to travel up to 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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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