QA Vigilance & 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

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