About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As a Senior Expert in Sterility Insurance, you will take on a vital role in ensuring the integrity and safety of our sterilization processes within clinical development.

Your expertise will drive quality assurance in sterilization practices to comply with industry standards and regulatory requirements while fostering a culture of continuous improvement and excellence.

Main Responsibilities:

- Managing task lists and interacting with other peripheral streams (maintenance, logistics, etc.)

- Communicating tasks to the project manager daily and via monthly KPIs.

- Tasks and deliverables for the project and authorities:

• Risk analyses (initiation, execution, conclusion, action plan)

• Drafting quality documents (test protocols/plans and reports, standard operating procedures, operating procedures)

• GAP analysis against GMP

• Scientific justification (documents) for deviations from regulatory requirements

• Monitoring action plans, investigations, and evaluation of out-of-specification (OOS) results

• Drafting the CCS DP

Requirements

About You

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe’s leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking an Expert in Quality Assurance for Injectables and Barrier Technology to strengthen our commitment to delivering high-quality products. In this pivotal role, you will lead quality assurance processes, ensure regulatory compliance, and drive continuous improvement initiatives.

Main Activities:

• Managing task lists and interacting with other peripheral streams (maintenance, logistics, etc.)
• Communicating tasks to the project manager daily and via monthly KPIs. Tasks and deliverables for the project and authorities:

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 opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

• Ensure the proper conduct of clinical trials in oncology from initiation to close-out
• Select investigator sites, set up studies, and monitor clinical trial progress
• Manage and track clinical trial budgets
• Handle required administrative tasks for study start-up and ongoing operations
• Conduct monitoring and co-monitoring visits at investigator sites
• Maintain regular communication with investigators and site staff
• Review clinical trial instructions and documentation as needed
• Prepare sites for audits and inspections, and actively participate in these processes
• Document and track any deviations or issues observed during the study

Requirements

About the Job

At Excelya, we empower our team to take bold steps in the world of clinical research. As a Demand Planning Specialist, you will be a vital player in ensuring that our operations run smoothly and efficiently. Your role will involve analyzing clinical and non-clinical demands, generating insightful reports, and contributing to the allocation of resources that impact patient care.

Main Responsibilities

• Consolidate clinical and non-clinical demand reports (API, DP, IMP).
• Generate IP/DP/DS allocation reports and associated documentation on a monthly basis and as needed.
• Plan and track product delivery, ensuring alignment with ERP systems.
• Contribute to the Regulatory Alignment report monthly and on demand.
• Submit Demand Planning Bulk Manufacturing Order requests.
• Update marketed product needs in internal systems.
• Prepare Product Availability Index (PAI) reports.
• Analyze existing processes to identify areas for optimization and improvement.

Requirements

About You

We seek individuals who are ready to embrace challenges and grow alongside us. To thrive in this role, you should possess:

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 opportunity to contribute to a dynamic, ambitious team in clinical-ops. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

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 opportunity to contribute to a dynamic, ambitious team in Global Safety. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

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 opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

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 opportunity to contribute to a dynamic, ambitious team in Safety. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

• Manage end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, escalation, translation, distribution, signature, archiving).

• Support site-related questions regarding invoice preparation with respect to submission of invoices in Amgen Payment System (eGPS)

• Support resolution of contract issues

• Support contracting with local GSO vendors

• Maintain contract tracking in appropriate systems

• Manage Confidential Disclosure Agreement process

• Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness

• Ensure payments are made in accordance with contracts

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 opportunity to contribute to a dynamic, ambitious team in Safety. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Qualify two sterilization processes at Sterigenics (Minerbio site):

• Develop and implement the qualification strategy.
• Prepare product qualification (PQ) documentation.
• Monitor purchase orders and validation report completion.

Ensure operational follow-up of product qualifications (PQ):

• Review lots/pallets to be reprocessed.
• Update and maintain the PQ tracking file.

Optimize the management of product qualifications at the Aubagne site:

• Identify opportunities for improvement (workflows, traceability, planning).

Strengthen the understanding and monitoring of Operational Qualification/Product Qualification (OQ/PQ) reports:

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 opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities