Associate Director, Clinical R&D QA

Overview

A global biopharmaceutical company on a mission to solve unmet medical needs, Incyte follows science to find solutions for patients. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first‑in‑class medicines for patients and a strong pipeline of products in Hematology, Oncology, Inflammation and Autoimmunity.

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

This position is responsible for providing GCP oversight of Clinical Development teams to the Head of Incyte Global R&D QA. The role also includes execution and management of Incyte QA GCP audits and provision of GCP guidance and advice across assigned Clinical Development programs. The Senior Manager Clinical R&D QA is the QA lead for clinical inspection activities related to clinical programs under its quality oversight.

• Provide QA GCP advice and support to Incyte Clinical Development/Operations functions and other relevant functions as assigned.
• Plan, schedule and conduct audits of Clinical Investigator Sites, Vendors, Trial Master Files and Clinical submission documents.
• Assist with the management of QA consultants performing audits on behalf of Incyte QA.
• Lead regulatory authority inspection activities for development programs assigned, including conducting pre‑inspection audits, inspection readiness activities and coordination/hosting inspection roles, as assigned.
• Coordinate responses and corrective/preventative actions from deviations, audit and regulatory findings.
• Assist with the maintenance of the clinical Quality Management System, including QA support for change control, deviations, review/revision of SOPs to ensure continuous process improvement.
• Stay abreast of clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials as appropriate.
• Alert Global Clinical R&D QA Upper Management of internal and external GCP compliance and clinical trial issues in a timely manner.
• Mentor junior Clinical QA staff as assigned.
• Promote Quality Culture with external R&D stakeholders, as assigned.
• Stay abreast of local or country clinical activities from Regional Clinical Operations members and ensure necessary QA oversight while serving as the Clinical R&D QA point of contact.
• Conduct GCP training for Incyte staff.
• Be knowledgeable and able to understand advanced operational, scientific and/or clinical research areas.
• Be thoroughly familiar with assigned Incyte compounds and protocols.

• Bachelor’s degree in a science or healthcare related discipline, or an equivalent degree from a university.
• 5 to 7 years of experience in a pharmaceutical or biopharmaceutical company in a GCP QA role or Clinical compliance role.
• Minimum of 5 years of experience performing GCP audits of investigator sites and/or CROs.
• English fluency written and spoken (the company language).
• Regulatory inspection experience as coordinator or in a key role.
• Ability to travel up to 30 %.
• Excellent written and oral communication skills.
• This role is office‑based.

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.