Global Quality Systems Coordinator

Jobtailor; Boulogne-Billancourt; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Jobtailor is seeking a senior Quality Management professional to define and oversee the QMS for Commercial Operations. You will collaborate with Medical Affairs, Pharmacovigilance, Regulatory Affairs, Supply Chain, and external partners to ensure GxP compliance and continuous improvement of quality processes.

The role involves leading harmonization, training, and audits across global and local sites, with a strong focus on risk management and CAPA remediation.

Qualifications

• Requires strong experience in designing, deploying, and improving quality processes across global and local organizations.
• Demonstrated ability to support regulatory inspections, audits, CAPA management, deviation management, and inspection readiness programs.
• Fluency in English and French with excellent written and verbal communication skills.
• Experience managing quality documentation, QTAs, procedures, policies, and document control systems.
• Ability to lead cross-functional quality initiatives with Medical Affairs, Regulatory Affairs, Safety, Supply Chain, affiliates, and external partners.

Responsabilités

• Define and oversee the QMS for Commercial Operations in collaboration with GxP-related functions.
• Lead the deployment, harmonization, and continuous improvement of QMS processes globally and locally.
• Coordinate audits, inspection readiness activities, and CAPA remediation efforts.
• Develop and oversee GxP training programs and Quality Management Reviews.
• Manage deviations, changes, supplier oversight, and QTA negotiation and management.

Connaissances

QMS deployment

GxP compliance

Quality governance

Cross-functional collaboration

Project management

Communication skills

Bilingual English/French

Formation

Life Sciences/Pharmacy/Chemistry degree

Outils

Document control software

Description du poste

Overview

Define and oversee the Quality Management System (QMS) for Commercial Operations in collaboration with GxP-related functions (Medical Affairs, Pharmacovigilance, Regulatory Affairs, Supply Chain, etc.). Act as the Commercial Operations representative in the development and maintenance of global quality standards, procedures, and Quality Technical Agreements (QTAs). Lead the deployment, harmonization, and continuous improvement of QMS processes across global and local organizations, affiliates, and business units. Manage quality documentation processes and support process owners, authors, and users through document review systems and training initiatives. Ensure ongoing GxP compliance, identify gaps, and drive remediation plans, corrective actions, and preventive actions (CAPAs). Support audit and inspection readiness activities, coordinate responses, and ensure effective follow-up of inspection and audit findings. Promote a strong quality and risk management culture, maintaining risk registers and driving continuous improvement initiatives. Develop and oversee GxP training programs and Quality Management Reviews to ensure organizational competence and compliance. Coordinate with sites, functions, and partners to resolve quality issues, manage deviations and changes, and support crisis prevention and management activities. Oversee quality activities involving external partners, including supplier oversight, product complaint management, QTA negotiation and management, and timely communication of APQRs to MAHs.

Requirements

• Scientific degree in Life Sciences, Pharmacy, Chemistry, Biotechnology
• Strong experience in Quality Management Systems (QMS) and GxP compliance within pharmaceutical, biotech, or healthcare environments.
• In-depth knowledge of GxP regulations, quality standards, risk management principles, and quality governance frameworks.
• Proven expertise in designing, deploying, and continuously improving quality processes across global and local organizations.
• Solid experience supporting regulatory inspections, audits, CAPA management, deviation management, and inspection readiness programs.
• Strong understanding of quality documentation management, including procedures, policies, quality agreements (QTAs), and document control systems.
• Demonstrated ability to lead cross-functional quality initiatives and collaborate effectively with Medical Affairs, Regulatory Affairs, Safety, Supply Chain, affiliates, and external partners.
• Strong project management, stakeholder management, communication, and problem-solving skills, with a focus on continuous improvement.
• Fluency in English and French, with excellent written and verbal communication skills.