At Excelya, driven by Audacity, Care, and Energy, we invite you to join our team as a Vigilance & Compliance Manager. This role focuses on overseeing QA Vigilance & Compliance activities, ensuring regulatory compliance, quality oversight, and continuous improvement across vigilance processes.
As a Compliance & Vigilance Manager you will be responsible to manage the Quality Assurance (QA) Vigilance and Compliance team for the Medical Care.
Your Main responsibilities :
- Lead and manage the QA Vigilance & Compliance team.
- Define and implement quality and compliance requirements across vigilance activities.
- Ensure compliance with applicable regulations, standards, and internal procedures.
- Provide quality oversight and support for vigilance processes and documentation.
- Manage third-party quality activities and coordinate internal and external audits.
- Oversee compliance processes and KPI monitoring for regulatory safety reporting.
- Support regulatory inspections and partner audits (ANSM, FDA, etc.).
- Promote quality culture, continuous improvement, and regulatory intelligence.
Requirements
At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.
- Master's degree in Pharmacy, Life Sciences, Quality Management, or a related field.
- Significant experience in Quality Assurance within the pharmaceutical, medical device, cosmetics, or healthcare industry.
- Strong knowledge of Pharmacovigilance, Materiovigilance, Cosmetovigilance, and applicable regulatory requirements.
- Solid understanding of GVP, GMP, ISO standards, health authority expectations, and quality systems.
- Experience managing audits, regulatory inspections, and quality oversight of external partners.
- Proven leadership and people management skills, with the ability to develop high-performing teams.
- Strong analytical, problem-solving, and continuous improvement mindset.
- Excellent stakeholder management, communication, and influencing skills in a cross-functional environment.
- Ability to manage multiple priorities in a complex and regulated environment.
- Fluent in English, French
Benefits
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique.
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
Skills Required
- Master's degree in Pharmacy, Life Sciences, Quality Management, or related field.
- Significant experience in Quality Assurance within the pharmaceutical, medical device, cosmetics, or healthcare industry.
- Strong knowledge of Pharmacovigilance, Materiovigilance, Cosmetovigilance, and applicable regulatory requirements.
- Solid understanding of GVP, GMP, ISO standards, health authority expectations, and quality systems.
- Experience managing audits, regulatory inspections, and quality oversight of external partners.
- Proven leadership and people management skills, with ability to develop high-performing teams.
- Strong analytical, problem-solving, and continuous improvement mindset.
- Excellent stakeholder management, communication, and influencing skills in a cross-functional environment.
- Ability to manage multiple priorities in a complex and regulated environment.
- Fluent in English and French.
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.
