About the role

Quality Assurance Manager overseeing critical QA processes and vendor management in the pharmaceutical industry. Leading audits, risk assessments, and maintaining quality management systems.

Responsibilities

**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.