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.
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:
·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.
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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During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
