Quality Manager

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.