Jobs at Excelya

3 open positions · From $900

Open roles

Head of CMC Data Management

Saclay, FranceFrom $900/yr

Join Excelya , where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role offers an exciting opportunity to lead and shape the Data Management strategy within a global CMC environment. As Head of CMC Data Management , you will drive data governance, lead a team of Data Managers, and prepare CMC data foundations to support future Data Science and Artificial Intelligence initiatives. Key Responsibilities Define and lead the CMC Data Management roadmap . Establish and maintain Data Governance frameworks, standards, and processes . Lead, coach, and develop a team of Data Managers . Define and manage data standards, reference data, and master data practices . Ensure data quality, consistency, reliability, and compliance across CMC activities. Oversee the Data Lifecycle Management process. Prepare and structure data to enable future Data Science and AI use cases . Collaborate closely with CMC, R&D, Data, Digital, and IT teams. Drive Data Transformation initiatives and promote a data-driven culture. Support strategic projects related to data management, governance, and digital transformation. Requirements Master's degree in Engineering, Data, Life Sciences, Computer Science, or a related field. Strong experience in Data Management. Strong experience in Data Governance, Data Quality, and Data Lifecycle Management . Proven experience managing and developing teams. Experience within the pharmaceutical industry , ideally in a CMC environment . Knowledge of Master Data Management (MDM), data standards, and information governance. Strong leadership, stakeholder management, and communication skills. Fluent English (written and spoken). Benefits Why join us? At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare. Here's what makes us unique: We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience. Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey. Excelling with kindness means evolving in an environment that values ​​your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission. Find more English Speaking Jobs in France on Arbeitnow

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Quality Assurance Pharmacist

Boulogne-Billancourt, FranceFrom $900/yr

At Excelya , we combine passion, scientific excellence, and collaboration to support our clients throughout the entire drug development lifecycle. We encourage our employees to be bold, take initiative, and unlock their full potential in an international, fast-growing environment. We are currently looking for a Quality Assurance Pharmacist to strengthen our Quality team and support pharmaceutical quality systems, product quality activities, and regulatory compliance initiatives. Key responsibilities : Quality Management System (QMS) Manage and maintain quality documentation including SOPs, procedures, and quality records. Coordinate document lifecycle activities, including creation, review, approval, archiving, and periodic reviews. Support and deliver GxP and quality-related training programs. Participate in internal audits, supplier audits, and health authority inspections. Manage quality events including deviations, CAPAs, change controls, and continuous improvement initiatives. Ensure compliance with applicable pharmaceutical regulations and quality standards. Product Quality Activities Manage product quality complaints and associated investigations. Support quality defect reporting and interactions with health authorities when required. Conduct risk assessments and quality impact evaluations. Participate in product recall and shortage management activities. Review Product Quality Reviews (PQRs) and monitor quality trends. Review and approve batch release documentation and distribution-related quality activities. Quality Oversight & Continuous Improvement Monitor quality KPIs and performance indicators. Contribute to Management Reviews and Annual Quality Reviews. Support cross-functional initiatives such as product launches, technology transfers, and portfolio optimization projects. Drive quality culture and promote continuous improvement across the organization. Collaborate closely with Manufacturing, Supply Chain, Regulatory Affairs, Pharmacovigilance, and Quality stakeholders. Requirements Education Doctor of Pharmacy (PharmD) mandatory. Strong experience in Quality Assurance within the pharmaceutical industry. Experience in pharmaceutical manufacturing or production environments is highly desirable. Registration as a Responsible Pharmacist (PRI) is considered an asset. Technical Skills Strong knowledge of: GMP (Good Manufacturing Practices) GDP (Good Distribution Practices), GVP and Pharmacovigilance requirements Proven experience managing: Deviations, CAPAs, Change Controls, Root Cause Analysis (RCA), Risk Management activities Experience with Quality Management Systems and tools such as: TrackWise, EDMS, SAP, Other electronic Quality Systems Language Fluent English, both written and spoken. Benefits Why join us? At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare. Here's what makes us unique: We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience. Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey. Excelling with kindness means evolving in an environment that values ​​your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission. Find more English Speaking Jobs in France on Arbeitnow

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Global Case Processing Specialist

Boulogne-Billancourt, A8, FRFrom $900/yr

About Excelya At Excelya, we combine passion, scientific excellence, and collaboration to support our clients across the entire drug development lifecycle. As a trusted partner of leading pharmaceutical and biotechnology companies, we are looking for a Pharmacovigilance Case Processing Officer to join a global safety team and contribute to the delivery of high-quality pharmacovigilance activities in an international environment. Missions As a Pharmacovigilance Case Processing Officer, you will support the Global Safety team and ensure the timely and compliant management of case processing activities. Your main responsibilities will include: * Acting as a point of contact for case processing vendors and responding to operational queries related to case management activities. * Monitoring case processing timelines and identifying root causes of delays in case reporting and submissions. * Performing regular quality reviews of pharmacovigilance cases, including: * + Data entry verification + MedDRA coding review + Narrative review and quality assessment + Consistency checks against source documentation * Managing and tracking corrections, clarifications, and follow-up requests with external partners and vendors. * Reviewing and approving quality control activities for assigned products and studies. * Supporting pharmacovigilance case reconciliation activities with business partners and external service providers in accordance with Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreements (PVA). * Contributing to deviation management activities, including Root Cause Analysis (RCA), CAPA development, and continuous quality improvement initiatives. * Collaborating closely with Pharmacovigilance Quality, Global Safety Operations, and cross-functional stakeholders. Requirements At Excelya, we encourage everyone to be bold, take initiative, and unlock their full potential. We are looking for professionals who share our values and are eager to grow in a dynamic and stimulating environment. Education : Bachelor's degree or higher in Pharmacy, Life Sciences, Nursing, Medicine, or a related scientific discipline. Experience : Solid experience in Pharmacovigilance with strong expertise in Case Processing and Case Management. Technical Skills : Hands-on experience with Argus Safety or equivalent safety databases. * Strong knowledge of global pharmacovigilance regulations and guidelines, including: EMA, FDA, MHRA, PMDA, Health Canada, ICH E2B, MedDRA, GVP, CIOMS * Excellent MedDRA coding and narrative writing skills. Experience performing quality control and quality review of safety cases. Familiarity with vendor management and outsourced pharmacovigilance activities. * Strong analytical, organizational, and problem-solving skills, Ability to manage multiple priorities in a fast-paced international environment. Excellent communication skills and ability to collaborate with global teams. * Proficiency in Microsoft Office tools. Languages : * Fluent English (written and spoken). Benefits Why join us? At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare. Here's what makes us unique: We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience. Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey. Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.

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