Global Quality Manager (Pharmaceuticals, EU-based)

Job summary

This role is essential within the Affiliate Quality Operations organization, focusing on the effectiveness, compliance, and continuous improvement of the Affiliate Quality Management System across Europe and global affiliates. The position involves collaboration with Quality leaders and stakeholders to ensure adherence to policies and regulatory requirements.

Qualifications

• Bachelor's degree in Life Sciences, a Scientific Discipline, Project Management, Business Management, or a related field; alternative educational backgrounds with relevant experience may be considered.
• At least 2 years of experience in a GxP-regulated role within the pharmaceutical industry.
• Strong knowledge of quality systems and compliance processes, including ICH guidelines.

Responsibilities

• Establish and maintain processes for reporting Quality KPIs across global affiliates.
• Coordinate inspection readiness activities throughout the global affiliate network.
• Ensure compliance of quality management systems, including documentation updates.
• Manage integration of Affiliate Quality SOPs with global procedures.
• Provide quality support to US Commercial Operations and assist with Product Technical Complaint activities.
• Support Global Change Control, Deviation, and CAPA processes.
• Lead implementation of global electronic quality systems.
• Communicate effectively with stakeholders regarding compliance and quality matters.

Skills

• Excellent interpersonal skills for building cross-functional relationships.
• Strong organizational and communication skills.
• Ability to identify and implement process improvements.
• Working knowledge of CAPA development and quality methodologies preferred.
• Experience with electronic quality systems and digital tools is advantageous.
• Proficient in Microsoft Office; familiarity with SAP, Veeva, TrackWise, and quality databases is desirable.
• Excellent written and verbal communication skills in English.

Education

• Bachelor's degree in a relevant field or equivalent experience.

Tools

• Microsoft Office, SAP, Veeva, TrackWise, SharePoint, and other quality databases.