Specialist, Compliance

Jubilant Pharma, LLC; Caen; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

QMS experience

Regulatory knowledge

Bilingual FR/EN

Quality auditing

Ausbildung

Bachelor of Science or Chemical Engineering

Tools

Microsoft Office

SAP

eQMS

Jobbeschreibung

At Jubilant Radiopharma, we help advance healthcare by manufacturing and delivering specialized products that support healthcare professionals and patients. We foster a collaborative, inclusive, and continuous improvement-driven environment where every team member has the opportunity to make a meaningful impact.

Role Overview

We are seeking a detail-oriented and collaborative Specialist, Compliance to join our Quality team. In this role, you will support the maintenance and continuous improvement of our Quality Management System while helping ensure compliance with applicable regulatory requirements and company procedures.

You will work closely with cross-functional teams to support compliance activities, audits, inspections, and continuous improvement initiatives.

Key Responsibilities

• Maintain current knowledge of industry practices to identify compliance risks and improvement opportunities.
• Act as a subject matter expert for Quality Systems, including Change Control (CC), CAPA, extensions, and related processes.
• Analyze Quality System performance metrics and identify areas for improvement.
• Prepare and complete Annual Product Quality Reviews according to established schedules.
• Oversee and follow up on CAPA, Change Control, Investigation, and Complaint systems to ensure timelines and closure requirements are met.
• Support compliance-related continuous improvement projects arising from trends, internal audit observations, and other quality indicators.
• Participate in internal audits and site inspection activities, including preparation, readiness, and execution.
• Perform additional duties as assigned.

Qualifications

• Bachelor of Science degree or Chemical Engineering degree.
• Minimum five (5) years of experience supporting Drug and/or Medical Device Quality Management Systems within the pharmaceutical, medical device, or biotechnology industries.
• 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.
• Ability to understand scientific issues and support work planning activities.
• Proficiency with Microsoft Office, SAP environments, and electronic Quality Management Systems (eQMS).
• French-English bilingualism is required. Proficiency in English is necessary to communicate with regulatory agencies, including the FDA, as well as with clients and suppliers located outside Quebec.
• Strong communication and interpersonal skills.
• Excellent organizational and time management skills.
• Strong technical and report-writing abilities.
• Analytical mindset and strong attention to detail.
• Ability to manage multiple priorities simultaneously.
• Team-oriented and results-driven approach.