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Global Quality Compliance and Performance Manager
vor 1 Monat
Job Summary
The Senior Manager Global Quality Compliance and Performance is a key member of the Global Quality team responsible for ensuring the oversight of Incyte Quality compliance and driving quality performance across various GxP disciplines, including pre-clinical and clinical development, manufacturing, and distribution, as well as post-marketing surveillance.
This strategic role develops and maintains quality documentation, including the Quality Manual and Policies, and sets up and maintains the GxP Quality risk management program to identify, manage, mitigate, and escalate quality risks.
In close collaboration with QA and operational teams, the Senior Manager will own core quality processes, such as Deviation, Change Control Management, and CAPA, ensuring their continuous compliance and performance to support GxP operations and the company's mission to bring innovative solutions to patients.
Key Responsibilities
- Quality Risk Management (QRM):
- Develop, implement, and maintain a comprehensive GxP quality risk management system.
- Own the company's 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 process performance and compliance.
- Audit Execution:
- Support the execution of 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 a subject matter expert 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.
