Vigilance Quality & Compliance Lead

Excelya; Paris; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Excelya in Paris is seeking a Vigilance & Compliance Manager to oversee QA vigilance and compliance activities, ensuring regulatory alignment across procedures. You will lead the QA Vigilance & Compliance team, define quality requirements, and coordinate audits with internal stakeholders and external partners to support regulatory inspections.

Fluent in English and French, you bring extensive experience in Pharmacovigilance and a strong leadership mindset to drive continuous improvement and a

Qualifications

• Experience in QA within pharma, medical device, cosmetics, or healthcare.
• 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.

Responsabilités

• 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

Connaissances

Quality Assurance

Pharmacovigilance

Regulatory knowledge

Audits

Leadership

Stakeholder mgmt

Problem solving

Communication

Prioritization

English & French

Formation

Master's degree in Pharmacy, Life Sciences, Quality Management, or related field

Description du poste

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

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'sleading mid-size CROwith thebest employee experience. Ourone-stop provider service modeloffering 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 caremeans 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.