Project Quality Assurance Expert – Permanent

Role Overview

• Participate in defining the Quality strategy and ensure its implementation in DMPC and R&D MC business and project activities
• Ensure processes comply with regulations, applicable standards and references (e.g., GLP, GMP, GCP, GVP, GDP, ICH, Pharmacopoeias, GDPR), applicable ethical standards and internal documentation
• Provide support and advice to business units and projects on Quality processes, notably for handling deviations, complaints, CAPA management and change requests
• Where applicable, contribute to the manufacture of experimental products by overseeing certification activities
• Ensure the compliance of clinical batches of medicinal products and medical devices
• Review, ensure consistency and validate business or project documentation identified within prevailing processes
• Ensure Quality control of third parties used by the business and within projects in coordination with relevant stakeholders
• Participate in defining and deploying internal and external audit programs
• Prepare for and participate in regulatory inspections (ANSM, FDA, ...) and partner audits within the scope of activity
• Contribute to the development of the document management system, acting as author, contributor, reviewer and/or approver of documents; also ensure documentation consistency with applicable regulations and reference standards
• Monitor regulatory and quality developments and communicate relevant information to concerned parties
• Promote a risk-based approach to activity management among business units, and contribute to the identification, analysis and control of quality risks
• Deploy quality culture and propose continuous improvement actions
• Participate in quality governance, notably by contributing to management reviews
• If authorized by the Group Quality Audit Department, act as Quality Auditor within the scope of authorization and apply methodology and rules in accordance with Group Quality directives

Requirements

• Pharmacist or chemist (Master’s degree) with additional training in Quality
• Minimum 8 years’ experience in Quality within the pharmaceutical industry, with specific experience in Project QA
• Expertise in QA for biologics is desirable
• Fluent English
• Strong functional and cross-functional skills
• Knowledge of Research, Pre-clinical Development and Clinical Development functions
• Very solid knowledge of applicable regulations in the area of expertise (GxP); familiarity with multiple reference standards is a plus
• Knowledge of ICH guidelines, notably ICH Q8, Q9, Q10 and Q11
• Awareness of expectations from regulatory authorities (FDA, ANSM, …)
• Proficient with Microsoft Office, document management systems and expert use of quality management systems

Benefits

• Profit-sharing and employee participation; Pierre Fabre employee shareholding plan with company contribution
• Health insurance and provident/practice insurance
• 16 RTT days in addition to annual paid leave
• Contribution toward collective transport/commuting costs