Jobs

    Director of Quality Assurance - Martinsried, Deutschland - WuXi AppTec

    WuXi AppTec
    WuXi AppTec Martinsried, Deutschland

    vor 4 Wochen

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    Beschreibung

    Director of Quality Assurance (STA Qualified Person - QP)

    • Located in Germany, Munich, with flexibility to travel and stay at WuXi STA Couvet, Switzerland site
    • Lead WuXi STA's QP organization in Germany
    • Establish WuXi STA's QP office, taking charge of related systems and processes
    • Responsible for QP certification of WuXi STA's products for both clinical and commercial use
    • Offer quality and compliance guidance to STA staff and sites, assisting in resolving quality issues promptly
    • Manage regulatory inspections and major client audits related to STA QP organization
    • Ensure proper resource allocation for projects, making adjustments as needed to meet timelines and quality standards
    • Promptly report significant quality impacts to upper management and communicate with customers for solutions
    • Communicate effectively with customers to guarantee satisfaction and understand their needs
    • Recruit and train new staff members, providing coaching for continuous skill enhancement

    Requirements:

    • PhD/Master's degree in pharmaceutical, chemical, or analytical sciences
    • Over 10 years of experience in Quality Assurance or relevant roles in regulated pharmaceutical settings
    • More than 6 years in people leadership and team management
    • Minimum 5 years in an EU Qualified Person role with necessary certifications
    • Fluency in German and English for effective presentation and communication

    Skillset:

    • Problem-solving, communication, quality system implementation, and team building abilities
    • Proactive in preventing quality issues and implementing quality systems
    • Strong in participative/directive and quality leadership
    • Resource optimization, continuous improvement, and operational efficiency expertise
    • Innovative problem analysis and solution skills
    • Ability to motivate, mentor, and collaborate effectively across cultures and work teams
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