Quality Systems & Compliance Specialist

Jubilant Pharma, LLC; Caen; On-site; EUR 65,000 - 90,000; Full time

Job summary

Jubilant Radiopharma in Caen, France, seeks a detail-oriented Specialist, Compliance to support Quality Management System maintenance and regulatory compliance across the organization. You will collaborate with cross-functional teams on audits, CAPA, change control, investigations, and continuous improvement initiatives.

The role requires in-depth knowledge of GxP regulations (US, Canada, Europe), FDA 21 CFR 820, ISO 13485, EU MDR, and fluent FR/EN communication with regulators and partners.

Qualifications

• Bachelor of Science or Chemical Engineering degree required.
• Minimum five (5) years of experience supporting Drug and/or Medical Device Quality Management Systems.
• Experience with FDA or Health Canada inspections is an asset.
• In-depth knowledge of GxP regulations for Canada, the United States, and Europe, as well as compendial standards (USP, Ph. Eur.).
• In-depth knowledge of FDA 21 CFR 820, ISO 13485, and EU MDR requirements.

Responsibilities

• Maintain and improve the Quality Management System.
• Support audits, inspections, and CAPA processes.
• Coordinate with cross-functional teams on compliance activities.
• Prepare and review Annual Product Quality Reviews and metrics.
• Oversee CAPA, Change Control, and investigation systems to ensure timely closures.
• Contribute to quality-driven continuous improvement projects.

Skills

QMS experience

Regulatory knowledge

Bilingual FR/EN

Quality auditing

Education

Bachelor of Science or Chemical Engineering

Tools

Microsoft Office

SAP

eQMS

Job description

Jubilant Radiopharma in Caen, France, seeks a detail-oriented Specialist, Compliance to support Quality Management System maintenance and regulatory compliance across the organization. You will collaborate with cross-functional teams on audits, CAPA, change control, investigations, and continuous improvement initiatives.

The role requires in-depth knowledge of GxP regulations (US, Canada, Europe), FDA 21 CFR 820, ISO 13485, EU MDR, and fluent FR/EN communication with regulators and partners.