Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.
As a QMS Support Manager, you will support a strategic site transformation project by ensuring the successful integration of quality management systems and documentation processes following the transfer of activities to the Gidy site. You will play a key role in document harmonization, training, quality oversight, and change management while ensuring compliance with GMP requirements and project timelines.
Key responsibilities :
- Quality management of new business requirements
- Implementation of defined processes and support to requestors
- Supplier monitoring and follow-up
- Management of quality events related to supplier management: Change Controls, deviations related to the process, including compliance with timelines, supplier notifications, supplier complaints
- Management of process-related documentation
- Participation in continuous process improvement initiatives
- Contribution to QMS (Quality Management System) department activities
- Participation in inspections and audits, including the management of action plans
- Support to business functions in monitoring and adhering to the process
Requirements
- Master's degree in Quality Assurance, Life Sciences, Pharmacy, Engineering, or a related field.
- Strong experience in Quality Management Systems (QMS) within a GMP-regulated environment.
- Strong knowledge of Quality Management Systems, GMP requirements, CAPA management, Change Controls, and deviations.
- Experience in document management, SOP creation, and quality documentation review.
- Detail-oriented and rigorous, Proactive, with a strong ability to make recommendations, Strong communication skills, Autonomous and self-driven, Adaptable, Persistent and resilient, Resourceful, Dynamic and motivated
- Experience monitoring KPIs and driving quality improvement initiatives.
- Good level in English.
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.
Skills Required
- Master's degree in Quality Assurance, Life Sciences, Pharmacy, Engineering, or related field
- Strong experience in Quality Management Systems (QMS) within a GMP-regulated environment
- Strong knowledge of GMP requirements, CAPA management, Change Controls, and deviations
- Experience in document management, SOP creation, and quality documentation review
- Experience monitoring KPIs and driving quality improvement initiatives
- Detail-oriented, proactive, strong communicator, autonomous, adaptable, resilient, resourceful, and motivated
- Good level of English
What We Do
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of Full-service CRO, FSP, and Resourcing solutions guided by compassion, care, and excellence. Founded in 2014 and headquartered in Paris, France, and operating in 28 countries across Europe, USA and India, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas, with speciality focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.
