Global Quality Compliance and Performance Leader
Vor 2 Tagen
The Quality Compliance and Performance Manager is a key member of the Incyte Quality team, responsible for ensuring the company's compliance with global quality standards and regulations.
Key Responsibilities
Quality Risk Management (QRM)
The Quality Compliance and Performance Manager will develop, implement, and maintain a comprehensive quality risk management system, ensuring the company's quality risk register is up-to-date and mitigation plans are in place.
They will also support other facilities/departments in implementing QRM, facilitate risk assessments, and ensure appropriate documentation and follow-up actions.
Quality Manual & Policies
The Quality Compliance and Performance Manager will develop and maintain the company's quality manual and policies, ensuring they are compliant with regulatory requirements and industry standards.
They will communicate and enforce quality policies across the organization, ensuring a culture of quality and compliance.
Quality Systems
The Quality Compliance and Performance Manager will own the following quality processes: Deviation Management, Change Management, and Corrective and Preventive Actions (CAPA) Management.
They will oversee the implementation and monitoring of these processes to ensure compliance and continuous improvement.
Audit Execution
The Quality Compliance and Performance Manager will support the execution of the Incyte internal and external GxP audit programs, contributing to best practices definition for audit management.
Data Integrity, Data Quality, and Data Governance
The Quality Compliance and Performance Manager will implement and maintain GxP data governance policies and procedures, ensuring data integrity, quality, and governance across all QA processes and systems.
They will define requirements for data quality and ensure their implementation, monitoring data quality and addressing any issues or discrepancies promptly.
Requirements
Qualifications
The Quality Compliance and Performance Manager must have a Bachelor's degree in Quality Management, Pharmacy, Life Sciences, or a related field, and at least 5 years of experience in Quality Assurance within the pharmaceutical industry.
They must have 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.
Other requirements include being a qualified auditor, having excellent analytical and problem-solving skills, and proficiency in quality management software and tools.
The Quality Compliance and Performance Manager must also have a proven experience in Risk Management and be able to work in a dynamic environment, handling multiple projects simultaneously.
Strong commitment to maintaining high-quality standards and continuous improvement is essential for this role.
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