CDD GLOBAL QUALITY MANAGEMENT SYSTEM AND COMPLIANCE MANAGER - M/F

Description :

The role consists of defining, structuring, and steering the Quality Management System (QMS) at a global level, ensuring its consistency, effectiveness, and compliance with regulatory requirements (GxP).

THE POSITION AIMS TO:

• ensure harmonization of quality practices across all group entities
• integrate risk and compliance issues into all processes
• support teams (sites, subsidiaries, global functions) in continuous improvement
• guarantee a constant level of preparedness for audits and inspections
• develop a true quality and risk management culture on an international scale

MAIN ACTIVITIES:

STEERING THE QUALITY SYSTEM

• Define, deploy, and improve the group QMS
• Ensure process harmonization across all entities
• Supervise quality tools (eDMS, eQMS) and their use

COMPLIANCE & REGULATION

• Guarantee compliance with regulatory requirements (GxP)
• Ensure regulatory monitoring and anticipate evolutions
• Manage the relationship with authorities and preparation for inspections

RISK MANAGEMENT & QUALITY PERFORMANCE

• Implement and monitor quality indicators (KPI)
• Manage risk management, deviations, and CAPA
• Supervise quality alerts and product recalls

AUDITS & INSPECTIONS

• Define and steer the audit strategy (internal/external)
• Ensure preparation and follow-up of regulatory inspections
• Manage associated action plans (CAPA)

OPERATIONAL & CROSS-FUNCTIONAL SUPPORT

• Support teams in process improvement
• Train and raise awareness among teams regarding quality requirements
• Intervene cross-functionally with IT, vigilance, clinical, HR, etc.

MANAGEMENT & GOVERNANCE

• Manage a team at a global level
• Implement effective quality governance
• Identify major risks and areas for improvement

Profile sought:

Pharmacist or engineer specialized in quality, with approximately ten years of experience in the pharmaceutical industry and recognized exposure to regulatory inspections.

The candidate must possess a solid mastery of regulations, audit practices, and industrial processes, as well as a good level of English allowing them to operate in an international environment. He/she is comfortable with analysis and documentary writing, and capable of driving continuous improvement processes (CAPA).

He/she operates effectively in cross-functional environments, with the ability to manage projects and coordinate different stakeholders, ideally within a logic of optimization and performance.

Possessing good leadership, he/she knows how to unite stakeholders, demonstrates pedagogical skills, and has excellent interpersonal skills. Rigor, organizational skills, analytical mindset, and results orientation complete this profile, which is also expected to be a source of proposals within a continuous improvement dynamic.

Fluent English in order to manage international partners.