Pharmaceutical Quality Assurance Project Manager (M/F)

SCIENTECH INTERIM is a temporary staffing agency specializing in the industrial and healthcare sectors. We support you in your job searches, both for temporary contract missions and for fixed-term/permanent recruitment. To apply for this offer, you can apply via our email address: under the reference STLCHEF.

Support the Quality Director for Operations, International Distribution, and Outsourcing in the structuring, deployment, and management of a corporate quality governance aimed at ensuring:

• Regulatory and GxP compliance of distribution, promotion, and commercial operations,
• Harmonization of quality systems and practices within subsidiaries,
• Effective supervision of the quality performance of subsidiaries and export distribution partners.

Activity 1 Ensure the mapping of export activities

• Contribute to the mapping of subsidiary models and export distribution partners.
• Implement and maintain a database of outsourced activities for export.
• Implement quality contracting frameworks: Quality Agreements and partner and alliance governance.

Activity 2 Effectively deploy the Quality Management System (QMS) within Commercial Operations

• Contribute to the definition of the Corporate QMS for Commercial Operations, in line with Group objectives, and in collaboration with other functions involved in GxP activities (e.g.: Medical Affairs, Pharmacovigilance, Regulatory Affairs, Supply Chain).
• Participate in the drafting, updating, and harmonization of global quality policies, standards, and procedures applicable to subsidiaries and distributors.
• Contribute to the definition of the roadmap for the deployment and/or consolidation of QMS elements within Commercial Operations, and manage its implementation.
• Ensure the monitoring of local QMS deployment by working with both global and local teams.

Activity 3 Quality supervision of subsidiaries and distributors

• Contribute to the definition and formalization of the quality governance model for commercial operations (corporate/local roles and responsibilities, quality committees, supervision processes).
• Implement, monitor, and consolidate key quality performance indicators (audits, inspections, CAPA, deviations, product complaints).
• Prepare quality management reviews for the Commercial Operations scope.
• Contribute to the identification, assessment, and monitoring of quality risks (risk register).
• Escalate critical situations and propose structured action plans.

Activity 4 Regulatory support, inspections, and deviation management

• Support subsidiaries and partners in preparing for inspections and audits, and managing observations and associated CAPA.
• Ensure consistency and cross-functional monitoring of major CAPA.
• Provide methodological support on deviations, change management, and quality investigation.
• Industrial Pharmacist, Engineer, or 3rd cycle scientific degree.
• Master (or equivalent) in Quality Management.
• English level C1

Required experience: Very good knowledge of GxP regulatory requirements

• Experience in relations with Health Authorities (inspection).
• Mastery of QMS, CAPA, audits, and risk management principles.