Quality Manager

Jobtailor; Gidy; Sur place; EUR 52 000 - 75 000; Plein temps

Résumé du poste

Jobtailor in France (Centre-Val de Loire, Gidy) is seeking a QA/QMS specialist to lead the integration of the Quality Management System (QMS) during transfer of operations and to harmonize documentation practices across sites.

You will coordinate cross-functional teams, manage training content, and drive continuous quality improvements by monitoring KPIs and implementing CAPAs, change controls, and deviations.

Qualifications

• Master's degree in Quality Assurance, Life Sciences, Pharmacy, Engineering, or related field.
• Strong experience with Quality Management Systems (QMS) in GMP environments.
• Knowledge of CAPA management, Change Controls, and deviations.
• Experience with document management, SOP creation, and quality document reviews.
• Proven ability to coordinate cross-functional teams on complex projects.
• Good IT affinity, including Microsoft Office and quality management systems.
• Experience monitoring KPIs and driving quality improvements.
• Good level of English.

Responsabilités

• Lead the integration of the QMS, including documentation and training activities for transfer of operations.
• Define and manage documentation scopes for transferred activities.
• Support drafting, review, and continuous improvement of quality documents (SOPs, procedures, forms).
• Ensure harmonization of documentation practices across impacted sites.
• Coordinate documentation activities and monitor project timelines to ensure delivery.
• Track action plans, identify risks and bottlenecks, and implement mitigations.
• Manage training activities from needs identification through content development, delivery, and effectiveness assessment.
• Support change management initiatives by facilitating adoption of new processes.
• Coordinate quality events such as Change Controls, CAPAs, and deviations.
• Develop and monitor KPIs and quality trackers for visibility and compliance.

Connaissances

QMS expertise

Cross-functional coordination

MS Office proficiency

Quality documentation

English proficiency

Formation

Master's degree in QA/Life Sciences/Engineering

Outils

MS Office

QMS software

Description du poste

Responsibilities

• Lead the integration of the Quality Management System (QMS), including documentation and training activities related to the transfer of operations.
• Define and manage documentation scopes associated with transferred activities.
• Support teams in the drafting, review, and continuous improvement of quality documents, including SOPs, procedures, and forms.
• Ensure harmonization of documentation practices across impacted sites.
• Coordinate documentation activities and monitor project timelines to ensure successful delivery.
• Track action plans, identify risks and bottlenecks, and implement mitigation actions to maintain project milestones.
• Manage training activities from needs identification through content development, delivery, and effectiveness assessment.
• Support change management initiatives by facilitating adoption of new processes and addressing resistance to change.
• Coordinate quality events linked to the project, including Change Controls, CAPAs, and deviations.
• Develop and monitor project KPIs and maintain quality trackers to ensure project visibility and compliance.

Requirements

• Master's degree in Quality Assurance, Life Sciences, Pharmacy, Engineering, or a related field.
• Strong experience in Quality Management Systems (QMS) within a GMP-regulated environment.
• Strong knowledge of Quality Management Systems, GMP requirements, CAPA management, Change Controls, and deviations.
• Experience in document management, SOP creation, and quality documentation review.
• Proven ability to coordinate cross-functional teams and manage complex projects.
• Good IT affinity, including Microsoft Office tools and quality management systems.
• Experience monitoring KPIs and driving quality improvement initiatives.
• Good level in English.

Core Competencies

Demonstrates expertise in Quality Management Systems (QMS) within GMP-regulated environments, with a strong focus on documentation management, training activities, and project coordination. Proven ability to drive quality improvement initiatives and manage cross-functional teams effectively.