Global Quality Compliance and Performance Manager

Vor 5 Tagen

Morges, Waadt, Schweiz Incyte Vollzeit
About the Role

We are seeking a highly skilled and experienced Global Quality Compliance and Performance Manager to join our team at Incyte. This is a critical role that will play a key part in ensuring the quality and compliance of our products and services.

Key Responsibilities
  • Quality Risk Management (QRM):
    • Develop, implement, and maintain a comprehensive GxP quality risk management system.
    • Own 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.
Requirements
  • Education:
    • Bachelor's degree in Quality Management, Pharmacy, Life Sciences, or a related field. Advanced degree preferred (Master's Degree)
  • Experience:
    • Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
  • Skills:
    • 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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