About the Job

At Excelya, driven by Audacity, Care, and Energy, we invite you to join our team as a Clinical Quality Manager. This pivotal role focuses on overseeing the quality management system within clinical operations to ensure compliance with regulatory requirements and continuous improvement of clinical processes.

As a Clinical Quality Manager, you will lead the development and implementation of quality strategies, manage audits and inspections, and collaborate closely with cross-functional teams to uphold the highest standards in clinical research.

Key Responsibilities

• Define, harmonize, and maintain quality procedures (SOPs) and ensure their effective implementation across teams.
• Lead and manage internal and external GCP audits, including preparation, execution, and follow‑up of CAPA plans.
• Ensure alignment with Global Quality teams and contribute to the consistency of processes and standards across the organization.
• Participate in quality comittees and drive continuous improvement of quality systems and processes.
• Lead, coach, and develop a team of quality professionals, supporting their performance and growth.
• Drive the evolution of working methods toward more efficient, structured, and compliant practices.
• Promote a strong quality culture, combining regulatory rigor with a pragmatic and business-oriented approach.
• Challenge existing processes and implement improvements to enhance performance and compliance.
• Prioritize and manage activities in a fast‑changing environment while ensuring regulatory requirements are met.
• Contribute to the structuring and scaling of the organization in a growth context.

About You

• Strong and extensive experience in clinical quality management within pharmaceutical, biotech, or CRO environments.
• Strong knowledge of ICH-GCP guidelines, EU CTR, FDA regulations, and other relevant standards.
• Proven leadership skills with experience managing audit programs and quality improvement projects.
• Excellent communication, organizational, and problem-solving skills.
• Scientific degree in life sciences, pharmacy, or related field; advanced degree is a plus.
• Fluency in English and French, both written and spoken.