Senior Quality Assurance
5 hours ago
About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting managerial opportunity to contribute to Excelya's Quality Assurance team.
In this hands-on and highly autonomous operational position, you will lead your team while actively shaping the organization's quality culture. You will collaborate across functions and oversee critical QA processes, including vendor management, audits, CAPAs, and continuous improvement initiatives. This position offers a dynamic career path within a stimulating and expanding QA environment.
Key Responsibilities
In this role you are expected to:
- Lead and support internal and external audits and inspections, ensuring proper preparation, execution, reporting, and follow-up.
- Conduct and oversee Risk Assessments and Risk Management activities across QA processes. Also manage vendor qualification, requalification,and GMP/GDP-related audits.
- Maintain and enhance the Quality Management System (QMS), including Change Controls, Deviations, CAPAs, and documentation governance.
- Contribute to writing, updating, and reviewing QMS documents.
In addition you will need to:
- Oversee the documentation system, ensuring compliance, accessibility, and version control.
- Develop, monitor, and report Quality KPIs, contributing to Quality Management Reviews.
- Maintain QA Agreements (QAAs), supplier/vendor records, the Site Master File (SMF), and the Quality Manual.
- Collaborate with QA team members on annual quality review activities, audit planning, training planning, and other core QA processes.
Finally, you will be required to:
- Contribute to the annual training plan, deliver internal training, and promote a strong quality culture.
- Drive cross-functional collaboration to ensure continuous improvement and timely CAPA implementation.
- Contribute to people management of the local QA team in close collaboration with the GQA Director
About You
We are looking for candidates who thrive in a fast-paced environment and share our commitment to quality and excellence:
- Experience: A minimum of 5 years of experience in quality assurance roles within the pharmaceutical or clinical research industry. Prior experience in Good Clinical Practices (GCP) is mandatory.
- Skills: In-depth knowledge of regulatory requirements (GMP, GCP, ISO, etc.) and excellent analytical and problem-solving skills.
- Education: Bachelor's degree in Life Sciences or related field; a Master's degree or relevant certification is a plus.
- Languages: Fluency in English is required; proficiency in French is an asset.
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here's what makes us unique—
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model — offering full-service, functional service provider, and consulting — enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
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