Associate Director, Clinical R&D QA US

Senior Manager Clinical R&D QA

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. 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 and Inflammation and Autoimmunity.

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

• 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 inspections activities for development programs assigned including conducting pre-inspection audits, inspection readiness activities and coordination/hosting inspection role, 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 with ensuring 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.
• Mentoring Junior Clinical QA as assigned
• Promote Quality Culture with external R&D stakeholders, as assigned
• Stay abreast of local/country clinical activities/initiatives from Regional Clinical Operations members and ensure necessary QA oversight in place as Clinical R&D QA Point of contact.
• Conduct GCP training for Incyte staff.
• Be knowledgeable and be able to understand advanced operational, scientific and/or clinical research areas.
• Be thoroughly familiar with assigned Incyte Compounds and protocol

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