Quality Assurance Officer

**About the Job**

At Excelya, we pride ourselves on embodying the values of **Audacity, Care, and Energy**. Joining our team means being part of a forward-thinking organization committed to excellence in healthcare.

As a **Quality Assurance Officer**, you will play a pivotal role in maintaining and enhancing the quality systems within our clinical research operations. Your expertise will contribute to ensuring compliance with applicable regulations and internal procedures, safeguarding the integrity of our studies.

The **R&D Quality Assurance (QA)** division oversees the **Quality Management System (QMS)** across R&D. The QMS Division is responsible for implementing and maintaining the Quality System, including:
- Coordination of R&D quality documents (creation, update, distribution).
- Training of R&D staff on SOPs/OPMs and applicable regulations.
- Defining and monitoring quality risk prevention strategies.
- Producing and analyzing quality indicators and metrics.

**Priority Tasks**:

- Lead **GLP/GCLP/GCP CRO qualification** activities.
- Support **QMS deployment** across Research & Translational Medicine.
- Conduct **quality assessments** of R&D teams, draft standardized reports, and propose corrective action plans.
- Develop and deploy **action plans** addressing identified deviations.
- Promote **QA culture** among scientific and laboratory teams (training, awareness, leadership support).

**Generic/Regular Activities**:

- Monitor international/national **regulations and guidelines** (GLP, GCLP, GCP, ICH, local regulations) and propose updates to processes or Quality Documents (QDs).
- Act as **QD Owner** or **QA Representative** for the creation, update, and validation of Quality Documents.
- Ensure compliance of QDs with regulatory, ICH, and internal requirements.
- Develop and deliver **quality training** (GCP, guidelines, regulations, SOPs).
- Contribute to **Quality Risk Prevention** strategies for assigned projects, in coordination with other QA Divisions.
- Track and ensure proper execution of **Corrective and Preventive Actions (CAPA)**.
- Participate in **regulatory inspections**, assisting in preparation, execution, responses, and follow-up activities.

**Deliverables**:

- Quality assessment reports and related action plans.
- Updated Quality Documents (QDs), SOPs, and operational manuals.
- Training materials and records for R&D staff.
- Periodic quality indicators and metrics reports.
- CAPA follow-up reports and compliance documentation.

**Requirements**:
**About You**

We are searching for individuals who are motivated, detail-oriented, and ready to embrace challenges as we work towards innovation and quality improvement in clinical research.
- ** Experience**:

- Experience in the pharmaceutical industry with knowledge in quality management (GxP).
- Experience in laboratory environment, GLP and GCP (or GCLP) needed.
- **Skills**:

- Experience in managing quality documents,
- Solutions oriented.
- Ability to work in a transversal manner, sense of contact.
- Proactive to predict issues and solve problems.
- **Education**: Degree in Life Sciences, Pharmacy, or a related field.
- **Languages**: Excellent written and oral communication (French & English),

**Benefits**

**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.