Global Quality Assurance Manager

vor 3 Wochen

Morges, Waadt, Schweiz Incyte Vollzeit
Job Summary:

Spearhead quality compliance and performance initiatives at Incyte, driving oversight and strategic documentation in the Global Quality team. Develop and maintain quality risk management programs, ensuring GxP discipline compliance across pre-clinical, clinical, manufacturing, and post-marketing surveillance. Collaborate with QA and operational teams to own core quality processes, guaranteeing continuous compliance and performance.

Key Responsibilities:
• Develop and implement comprehensive GxP quality risk management systems
• Own quality risk registers and monitor mitigation
• Support facility implementation of QRM and facilitate risk assessments
• Train staff on QRM and associated tools
• Develop and maintain quality manual and policies
• Ensure compliance with regulatory requirements and industry standards
• Communicate and enforce quality policies across the organization
• Own quality processes: Deviation Management, Change Management, and CAPA Management
• Oversee implementation and monitoring of these processes for compliance and continuous improvement
• Identify e-system enhancements and partner with digital quality and IT to implement
• Define and monitor metrics to assess process performance and compliance
• Support Incyte internal and external GxP audit programs
• Contribute to best practices definition for audit management
• Implement and maintain GXP data governance policies and procedures
• Ensure data integrity, quality, and governance across QA processes and systems
• Define requirements for data quality and ensure implementation
• Monitor data quality and address issues promptly
Requirements:
• Bachelor's degree in Quality Management, Pharmacy, Life Sciences, or a related field. Advanced degree preferred
• 5+ years of experience in Quality Assurance within the pharmaceutical industry
• In-depth knowledge of quality management systems, quality standards, and pharmaceutical regulations
• 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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