Directeur d'unité supervisant une équipe gérant des réclamations civiles, cargo et responsabilité. Responsable de l'élaboration de plans d'affaires et des relations avec d'autres unités opérationnelles.
About the role
- Associate Director of Quality Systems in a pharmaceutical company ensuring compliance and quality in investigational medicinal products. Leading transformation initiatives and cross-functional collaboration for quality practices.
Responsibilities
- Drive Quality Systems Transformation initiatives focused on deviation management, CAPA effectiveness, change management, quality risk management, and data governance.
- Strengthen standardization and continuous improvement of global quality system processes to ensure consistent application, transparency, and inspection readiness.
- Establish and reinforce master data management and data integrity controls that underpin right-first-time execution and regulatory confidence.
- Provide quality system expertise to ensure processes remain in a state of control, compliant with global regulatory requirements and internal standards.
- Act as a change agent to enable durable quality system and quality culture improvements through system-level rigor, governance, and traceability.
- Partner cross-functionally with site and functional teams to identify systemic gaps, influence adoption of global standards, and implement sustainable solutions.
- Support management oversight activities by developing and monitoring quality system metrics and key performance indicators.
- Author, review, and approve quality system documentation and governance materials in accordance with established procedures.
- Maintain expert-level knowledge of GxP requirements, regulatory expectations, and industry trends, providing interpretation and guidance to stakeholders.
Requirements
- Minimum 8 years (B.S./M.S.) or 5 years (Ph.D.) in the pharmaceutical or biotechnology industry.
- Demonstrated experience in Quality Systems, Quality Assurance, Compliance, or related GxP-regulated roles.
- Extensive working knowledge of global GxP requirements and Pharmaceutical Quality System principles.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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