Excelya

Insurance

• Quality monitoring of product development projects (in-house or outsourced) for CMC (Chemical Manufacturing and Control)
• As a member of the CMC project team in the role of QA-CMC, you will ensure the overall quality of pharmaceutical development activities from the active ingredient to the investigational medicinal product (end to end)
• Participating in the drafting and updating of quality agreements
• Evaluating and ensuring the compliance of deliverables and development support studies necessary for the preparation of drug specification files (PSF) with current quality standards (quality review of Product Specification Files, techniques, standards, protocols/stability reports/validation and analytical transfer, expiry dates, MBR, etc.) and deliverables supporting the drafting of marketing authorisation files
• Reviewing files for clinical batches of active ingredients and investigational injectable medicinal products with a view to their release
• Assessing deviations, change control, anomalies, OOX, CAPA, etc.
• Leading or contributing to the necessary risk analyses justifying the CMC development strategy
• Also participating in due diligence.
• The products concerned may be injectables or dry forms.

CMC Project Quality Assurance

Sales

• **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. As we expand our footprint in Belgium (and the Netherlands), we’re looking for a strategic and entrepreneurial Business Unit Director to build and scale our resourcing business from the ground up. This is a unique opportunity to shape the future of our BeNe operations, lead a high-impact team, and contribute to Excelya’s ambitious 2030 vision.
• **Main Responsibilities**
• - Design and execute a **strategic prospection plan** to grow our client base across Belgium (and in the Netherlands as opportunities arise).
• - Build and lead a high-performing team of **consultants**.
• - Recruit and structure the **Belgian sales team**, to support business development and client engagement.
• - Drive **business development** through client meetings, needs qualification, and solution proposals.
• - Collaborate with **Talent Acquisition** to recruit top-tier consultants and ensure optimal staffing.
• - Monitor and optimize **gross profitability**, negotiating daily rates aligned with business goals.
• - Foster a strong team culture through regular follow-ups, team-building activities, and informal moments.
• - Act as a key link between the Belgian BU and Excelya HQ, embodying and promoting our core values.

Business Unit Director, Sales

Clinical Operations

• **Main Responsibilities**
• - ***Lead and coordinate**** execution with internal teams, including Medical Directors and Clinical Development leaders.*
• - ***Validate and monitor**** CRO project plans, ensuring alignment with study objectives and risk mitigation strategies.*
• - ***Ensure compliance**** with Good Clinical Practice (GCP), local regulations, and internal guidelines.*
• - ***Facilitate communication**** and collaboration between internal teams, CROs, and investigators.*
• - ***Manage and guide**** cross-functional clinical teams and external service providers.*
• - ***Supervise study operations****, from startup to completion, including feasibility assessments, site selection, and regulatory processes.*
• - ***Monitor and control**** trial budgets, vendor selection, and contract negotiations.*
• - ***Track and report**** study progress, addressing deviations and ensuring high-quality data.*
• - ***Support quality assurance****, audits, and continuous improvement initiatives across clinical projects.***

Global Clinical Project Manager – Early Phase Oncology

Data Scientist

• Collect and challenge business requirements; document meeting outcomes and key decisions.
• Perform functional and technical testing of the VITRO application
• Conduct data quality control on the VITRO database
• Write and update user documentation (guides, training materials, business rules) in both French and English
• Review and track master data imports in DEV, UAT, and PROD environments
• Ensure functional understanding of in vitro data applications and their integration with the VITRO product
• Validate and monitor links between VITRO and master data/reference systems
• Implement data integrity rules and ensure compliance
• Execute data management decisions and directives defined by the internal data manager
• Collaborate closely with Agile team members and business stakeholders

Data Manager

Software Engineer

• Design, develop, and maintain SharePoint-based solutions tailored to pharmaceutical R&D and business needs.
• Customize SharePoint sites and workflows to support document management, collaboration, and compliance.
• Ensure alignment with regulatory standards (e.g. GxP, 21 CFR Part 11) and internal quality procedures.
• Collaborate with IT, Quality, and R&D teams to translate functional requirements into scalable SharePoint solutions.
• Develop and maintain documentation for solutions, architecture, and best practices.
• Provide technical support and user training to promote adoption of SharePoint platforms.
• Participate in Agile ceremonies (daily stand-ups, sprint planning, reviews).
• Contribute to the governance of SharePoint usage across business units.
• Ensure integration with other Microsoft 365 tools (Power Automate, Teams, OneDrive).
• Continuously monitor and improve performance, usability, and user experience of SharePoint environments.

SharePoint Developer

• Analyze and document current data flows across R&D and Translational Medicine departments
• Identify bottlenecks and propose solutions in existing data management processes
• Design and implement tools and processes to enhance data quality and traceability
• Perform data analyses to ensure accuracy, consistency, and compliance with internal standards
• Collaborate with data managers, IT, reference data teams, and business stakeholders to align efforts
• Support the development of user documentation and quality control protocols
• Develop and maintain SQL and Python scripts for data validation and quality monitoring
• Work closely with the Data Quality Lead to ensure alignment of all data quality initiatives
• Contribute to weekly progress updates and monthly activity reports
• Participate in the preparation of test and validation documents related to data workflows

Data Manager, Quality

Research Analyst

• **Main Responsibilities:**
• - Perform closeout visits in accordance with study protocols and GCP guidelines.
• - Ensure timely and accurate collection of study data, including on-site source data verification.
• - Assist in the preparation of monitoring reports, ensuring compliance with internal and external standards.
• - Provide training to site staff on protocol requirements, data entry, and study procedures.
• - Communicate effectively with study teams and site personnel regarding study progress and challenges.
• - Identify and resolve issues that may impact the integrity of data or the rights and safety of participants.
• - Support the preparation for audits and inspections, maintaining compliance at the site level.

Clinical Research Associate – Closeout

• **Position Overview**
• We are seeking a meticulous and proactive **Assurance Quality Officer** to join our Quality Assurance team. In this role, you will play a critical part in ensuring that our processes and deliverables meet the highest standards of quality, compliance, and operational excellence.
• The Assurance Quality Officer is responsible for supporting the development, implementation, and continuous improvement of the Quality Management System (QMS) across clinical projects. You will work collaboratively with cross-functional teams to ensure adherence to regulatory requirements and organizational policies.
• **Key Responsibilities:**
• - Conduct regular audits of processes and operations to ensure compliance with internal and external quality standards.
• - Review and approve quality-related documentation such as SOPs, work instructions, and validation protocols.
• - Assist in the investigation of quality issues, deviations, and non-conformities, and support corrective and preventive actions (CAPA) processes.
• - Provide training and guidance to team members on quality processes and best practices.
• - Monitor and report on quality metrics and performance indicators.
• - Participate in the continuous improvement of the Quality Management System.

Quality Assurance Officer

Product Manager

• **About the Job**
• Join Excelya, where **Audacity, Care, and Energy** define who we are and how we work. As a pivotal part of our leadership team, we are looking for a **Business Unit (BU) Business Owner** to drive the strategic direction and operational performance of your assigned unit within our organization.
• In this role, you will leverage your deep understanding of the market and business landscape to develop and implement strategies that align with Excelya’s vision and objectives, ensuring sustainable growth and profitability.
• **Main Responsibilities:**
• **Strategic alignment**
• - Capture and analyze R&D business needs and translate them into BI/Data requirements.
• - Ensure that BI products and data initiatives are aligned with R&D strategic priorities.
• - Act as the voice of the business within the BI & Data product portfolio.
• **Vision & roadmap**
• - Define and communicate a clear vision for BI and data usage across R&D.
• - Contribute to the definition and prioritization of the BI/Data roadmap, balancing business value, feasibility, and resources.
• - Anticipate emerging business needs and ensure the portfolio evolves accordingly.
• **Value creation & performance**
• - Maximize business impact through dashboards, analytics tools, and digital products.
• - Define and monitor key performance indicators (KPIs) to measure adoption, usage, and business value generated.
• - Continuously improve BI solutions to increase efficiency, data accessibility, and scientific decision-making.
• **Adoption & change management**
• - Promote adoption of BI solutions and foster a strong data-driven culture within R&D.
• - Support end-users in leveraging dashboards and analytical tools effectively.
• - Act as a change agent by communicating benefits, best practices, and success stories.
• **Collaboration & governance**
• - Work closely with Product Owners, Tech Leads, Data Engineers, and other stakeholders to ensure solution quality and relevance.
• - Facilitate communication between business teams and technical experts.
• - Contribute to data governance initiatives, ensuring proper usage, security, and compliance with regulatory requirements.

AI & Analytics Product Manager – R&D

QA Engineer

• **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.
• - Provide **guidance and support** to R&D staff on applying quality standards and implementing QA policies.
• - 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.

Compliance

• Manage regulatory submissions for medical devices in accordance with U.S. FDA and EU MDR/IVDR requirements
• Review and assess technical documentation for compliance with regulations, including risk assessments and clinical evaluations
• Prepare and maintain regulatory files and submissions, ensuring accuracy and completeness
• Collaborate with cross-functional teams to ensure timely product launches and compliance with post-market surveillance activities
• Stay updated on regulatory changes and advise the organization on potential impacts on products and processes

Regulatory Affairs Officer, Medical Device

Data Analyst

• Analyze inventory data and derive actionable insights to support decision-making processes
• Develop and maintain inventory analysis models, ensuring data integrity and accuracy
• Conduct regular audits and assessments of inventory data to ensure compliance with standards
• Identify trends, anomalies, and opportunities for improvement and provide comprehensive reports to stakeholders
• Work with cross-functional teams to streamline processes and establish best practices for inventory management
• Support the implementation of data quality measures and corrective actions for discrepancies
• Utilize data visualization tools to present findings and facilitate understanding among non-technical stakeholders

Data Analyst – Inventory Management and Data Quality

Clinical Research

• Paramétrage financier des contrats dans l’outil de gestion des essais cliniques : Assurer la justesse des paramétrages. Garantir la compatibilité avec le processus de facturation et la gestion des patients inclus dans l’essai.
• Facturation des études cliniques académiques et industrielles (côté investigateur, gérées par la DRC) : Préparer les pré-factures (coûts, surcoûts, refacturations). Suivre le processus jusqu’à l’émission de la facture par la DAGF. Assurer la refacturation au promoteur le cas échéant (ex. nuitées, désarchivage, etc.).
• Suivi de la facturation et des paiements : Mettre à jour et suivre un tableau de bord / outil de gestion des études. Vérifier l’adéquation de QUALIAC pour le suivi et le transfert des montants facturés. Relancer les factures impayées. Appuyer la DAGF pour les opérations de rapprochement de trésorerie.
• Contribution au reporting financier : Préparer les rapports de facturation et de paiement pour la DRC, les comités et les départements concernés. Transmettre les données financières issues du suivi de facturation au responsable contrats et facturation.

Gestionnaire de facturation, recherche clinique

Manager

• Ensure staff deliver services on time, with high quality standards and within agreed budget
• Manage, evaluate, develop and retain supervised staff
• Assess resource requirements, allocate team members and coordinate activities; responsible for resourcing and planning
• Ensure supervised staff are adequately trained and comply with Excelya and client SOPs, policies, guidelines, and regulations
• Identify training needs and collaborate with Human Resources and QA for training implementation
• Assist in audits and inspections and prepare CAPA plans; support CAPA implementation
• Escalate quality issues to Head of department and QA
• Ensure supervised staff meet expected study timelines and deliverables within the agreed budget
• Support direct reports with issue resolution and study risk management plans

Line Manager

• Provide SDTM Programming input for Data Management activities dedicated to one Sponsor
• Ensure all clinical programming aspects per client SOPs are delivered to high quality
• Responsible for building SDTM data models using SAS and other ETL tools
• Set up SAS QC environments and programs for data set validation
• Apply deep understanding of SDTM implementation in Oncology and Cardiovascular therapeutic areas
• Use Pinnacle 21 Enterprise for data set validations and ensure IG requirements are met
• Maintain regulatory compliance through knowledge of ICH GCP and relevant ICH, EU, or FDA guidelines
• Collaborate within a dynamic team to drive innovation and contribute to clinical research objectives

Lead SDTM Programmer

• Manage end-to-end logistics of investigational medicinal products (including placebos) for global clinical trials
• Oversee the supply chain for clinical materials and biological samples required in international studies
• Centralize clinical supply needs (IMPs, clinical supplies, biological analyses) and establish a monthly planning shared with the industrial department and subcontractors
• Act as the main interface between clinical teams and cross-functional units (pharmacy coordination, quality control, release, procurement, regulatory, legal, subcontractors)
• Draft or coordinate the drafting of traceability documents related to clinical supply logistics (shipping requests, returns, AoR, etc.), or supervise these activities when outsourced
• Supervise and monitor subcontracted activities (CROs, CMOs) related to IMP packaging, clinical supply, and biological sample storage
• Investigate and analyze deviations or issues with subcontractors (secondary packaging, sample storage) and implement CAPAs
• Ensure compliance with company SOPs, GMP/GCP, and all applicable regulatory requirements
• Contribute to regulatory intelligence related to clinical supply chain activities and ensure process optimization
• Provide regular reporting and proactively escalate risks or delays impacting study timelines

Clinical Supply Manager

Database Administrator

• Join Excelya — contribute to a dynamic Pharmacovigilance team driving innovation in clinical research and professional growth.
• Provide functional administration of the pharmacovigilance database including configuration requests, study and product setup, and expedited reporting rules.
• Support implementation and monitoring of new and existing E2B exchanges with authorities and partners, ensuring timely issue resolution.
• Contribute to database operational maintenance, managing anomalies and system enhancements.
• Gather business needs for Business Objects reports, support report development, and perform validation/verification activities.
• Collaborate with Global Safety and local teams to ensure smooth database operations and compliance with pharmacovigilance requirements.
• Contribute to additional pharmacovigilance-related activities as required by management.

CMC Project Quality Assurance

Business Unit Director, Sales

Global Clinical Project Manager – Early Phase Oncology

Data Manager

SharePoint Developer

Data Manager, Quality

Clinical Research Associate – Closeout

Quality Assurance Officer

AI & Analytics Product Manager – R&D

Quality Assurance Officer

Regulatory Affairs Officer, Medical Device

Data Analyst – Inventory Management and Data Quality

Gestionnaire de facturation, recherche clinique

Line Manager

Lead SDTM Programmer

Clinical Supply Manager

Safety Database Administrator