Global Quality Manager (m/f/d)

Your Profile:

• Bachelor's degree in Life Sciences, a Scientific Discipline, Project Management, Business Management, or a related field. Candidates with alternative educational backgrounds and significant relevant experience will also be considered.
  
• Minimum of 2 years' experience in a pharmaceutical industry GxP-regulated role.
  
• Strong knowledge of quality systems, compliance processes, and pharmaceutical industry regulations, including ICH guidelines and industry standards.
  
• Demonstrated ability to work independently, take ownership of assigned projects, and deliver results with minimal supervision.
  
• Excellent interpersonal skills with the ability to build effective cross-functional relationships and work successfully within global teams.
  
• Strong organizational, communication, influencing, and stakeholder management skills.
  
• Ability to identify process improvement opportunities and implement practical, innovative solutions.
  
• Working knowledge of CAPA development and quality system methodologies is preferred.
  
• Experience supporting or implementing electronic quality systems and digital quality tools is advantageous.
  
• Strong computer skills, including Microsoft Office applications. Experience with SAP, Veeva, TrackWise, SharePoint, collaboration tools, or quality databases is desirable.
  
• Excellent written and verbal communication skills in English.
  
• Limited travel may be required.

Your Tasks:

• Establish and maintain processes for reporting Quality KPIs across global affiliates.
  
• Coordinate inspection readiness activities throughout the global affiliate network.
  
• Support quality management system compliance activities, ensuring policies, SOPs, work instructions, and related documentation remain current, effective, and aligned with business and regulatory requirements.
  
• Manage the integration of Affiliate Quality SOPs with Global CSL procedures and facilitate procedure updates to incorporate affiliate and local requirements.
  
• Provide quality support to US Commercial Operations as required.
  
• Support Product Technical Complaint (PTC) activities for the US market.
  
• Support Global Change Control, Deviation, and CAPA processes across assigned regions.
  
• Support and perform product release activities for the US market and Kankakee-manufactured export products, collaborating with manufacturing site representatives as needed.
  
• Lead and/or support implementation of global electronic quality systems such as SAP, Master Data Governance, and DocNet.
  
• Ensure effective communication with internal and external stakeholders regarding progress, improvements, risks, and compliance-related matters.

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