Overview

Summary

The Manager / Senior Manager Global Quality Compliance and Performance is a member of the Global Quality team assuring the oversight of Incyte Quality compliance and driving quality performance at Incyte, spanning the different GxP disciplines (pre-clinical and clinical development, manufacturing and distribution, post marketing surveillance).

This global position develops and maintains strategic Quality documentation (Quality Manual and Policies). This management role is responsible to set-up and maintain the GxP Quality risk management program allowing proper identification, management, mitigation and escalation of Quality risks.

In close collaboration with other QA and operational teams, he / she will own core Quality processes (Deviation, Change control Management, CAPA) assuring their continuous compliance and performance supporting GxP operations and our mission to bring innovative solutions to patients.

He / she will develop a robust data governance program to ensure reliability, integrity and quality of GxP quality information supporting a data driven Quality Organization.

The role will support the execution of the GxP audit program as a Senior auditing resource.

Key Responsibilities

• Quality Risk Management (QRM) :
• Develop, implement, and maintain a comprehensive GxP quality risk management system.
• Owns the company GxP quality risk register and monitor mitigation.
• Support other Facilities / Departments in implementing QRM, facilitate risk assessments and ensure appropriate documentation and follow-up actions.
• Train staff on QRM and associated tools.

Quality Manual & Policies :

Quality Systems :

Audit Execution :

Data Integrity, Data Quality, and Data Governance :

Inspection Program :

Qualifications

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.

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