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):
o Develop, implement, and maintain a comprehensive GxP quality risk management system.
o Own the company GxP quality risk register and monitor mitigation.
o Support other Facilities / Departments in implementing QRM, facilitate risk assessments and ensure appropriate documentation and follow-up actions.
o Train staff on QRM and associated tools.
Quality Manual & Policies:
* Develop and maintain the company's quality manual and policies.
* Ensure all quality policies are in compliance with regulatory requirements and industry standards.
* Communicate and enforce quality policies across the organization.
Quality Systems:
* Own the following quality processes: Deviation Management, Change Management, and Corrective and Preventive Actions (CAPA) Management.
* Oversee the implementation and monitoring of these processes to ensure compliance and continuous improvement.
* Identify e-system enhancements needs and partner with digital Quality and IT to implement.
* Manage the process training strategy.
* Define and monitor metrics to assess the process performance and compliance.
Audit Execution:
* Support the execution on the Incyte internal and external GxP audit programs.
* Contribute to best practices definition for audit management.
Data Integrity, Data Quality, and Data Governance:
* Implement and maintain GXP data governance policies and procedures.
* Ensure data integrity, quality, and governance across all QA processes and systems.
* Define requirements for data quality and ensure their implementation.
* Monitor data quality and address any issues or discrepancies promptly.
Inspection Program:
* Act as SME during inspections / audits.
* Support received audits, including inspections, hosted by the company’s facilities.
Qualifications
* Bachelor's degree in Quality Management, Pharmacy, Life Sciences, or a related field. Advanced degree preferred (Master’s Degree).
* Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
* In-depth knowledge of quality management systems, quality standards (e.g., GMP, GLP), and pharmaceutical regulations (e.g., FDA, EMA) in at least two GxP areas.
* Qualified auditor.
* Excellent analytical and problem-solving skills.
* Proficiency in quality management software and tools.
* Proven experience in Risk Management.
* Ability to work in a dynamic environment and handle multiple projects simultaneously.
* Strong commitment to maintaining high-quality standards and continuous improvement.
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