Director, Business Operations (Global Quality Control)(m/w/x)

Beschreibung

You will lead the strategic design and optimization of global QC frameworks to ensure scalable vaccine production. By driving governance and cross-functional coordination, you'll bridge the gap between development and commercial readiness.

Anforderungen

• •Degree in Biotechnology, Pharmacy, or Engineering
• •Experience in QC or Analytical Operations
• •Leadership in GMP operational systems
• •Understanding of cGMP and regulatory requirements
• •Ability to implement governance models
• •Vendor management and CDMO/CRO collaboration
• •Exceptional communication and negotiation skills
• •Analytical and data-driven decision-making skills
• •Passion for process improvement and automation

Aufgaben

• •Design and execute global QC operational strategies
• •Align QC operations with clinical and commercial goals
• •Implement continuous improvement and PDCA frameworks
• •Define and monitor operational KPIs and metrics
• •Lead automation and data visibility initiatives
• •Establish governance frameworks for analytical operations
• •Formalize business processes using RASCI principles
• •Enhance QMS infrastructure and harmonize SOPs
• •Embed data integrity principles in all practices
• •Lead regulatory inspection and audit readiness
• •Oversee business system development and validation
• •Manage equipment qualification and maintenance programs
• •Lead site planning and outsourcing strategies
• •Develop business cases for laboratory expansion
• •Mentor a global team of QC professionals
• •Drive technical training and compliance programs
• •Harmonize practices across various functional departments
• •Represent QC operations in governance committees

Tools & Technologien

Benefits