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 Quality 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 :- Lead the integration of the Quality Management System (QMS), including documentation and training activities related to the transfer of operations.
- Define and manage documentation scopes associated with transferred activities.
- Support teams in the drafting, review, and continuous improvement of quality documents, including SOPs, procedures, and forms.
- Ensure harmonization of documentation practices across impacted sites.
- Coordinate documentation activities and monitor project timelines to ensure successful delivery.
- Track action plans, identify risks and bottlenecks, and implement mitigation actions to maintain project milestones.
- Manage training activities from needs identification through content development, delivery, and effectiveness assessment.
- Support change management initiatives by facilitating adoption of new processes and addressing resistance to change.
- Coordinate quality events linked to the project, including Change Controls, CAPAs, and deviations.
- Develop and monitor project KPIs and maintain quality trackers to ensure project visibility and compliance.
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.
- Proven ability to coordinate cross-functional teams and manage complex projects.
- Good IT affinity, including Microsoft Office tools and quality management systems.
- 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
- Proven ability to coordinate cross-functional teams and manage complex projects
- Good IT affinity, including Microsoft Office tools and quality management systems
- Experience monitoring KPIs and driving quality improvement initiatives
- Good level in 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.
