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.
Our Global Quality Assurance group is looking for a Manager/Sr. Manager, Clinical QA.This role provides global audit support and GCP oversight of Clinical Operations teams to the Head of QA-GCP. The Manager/SrManager executes and manages QA-GCP audits and GCP guidance and advice across assigned departments within Incyte's Clinical groups.
Essential Functions of the Job (Key responsibilities)
Plan, schedule and conduct audits of Clinical Investigator Sites, CROs, and Clinical submission documents.
Coordinate responses and corrective actions from audit findings.
Provide GCP advice and support to Incyte Clinical Operations and other relevant 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 with the development, maintenance, and reporting of metrics defined by QA.
Support Quality management initiatives and Quality improvement plans for QA and defined business
Become thoroughly familiar with assigned compounds and protocols.
Provide support for regulatory authority inspections including conducting pre-inspection audits of sites.
Assist with the management of QA consultants performing audits.
Qualifications (Minimal acceptable level of education, work experience, and competency)
5 years' experience in a pharmaceutical or bio-pharmaceutical company in a GCP QA role with a minimum of 3years' experience performing GCP audits of CROs and investigator sites.
Strong written and oral communication skills.
Prior Regulatory inspection experience desired.
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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We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.
1801 Augustine Cutoff
Wilmington, Delaware 19803