Senior Director, Global Quality Supply

Role Overview

• Drive the global quality strategy for packaging, labeling, serialization, storage, and distribution to ensure inspection readiness and regulatory compliance across regions
• Provide senior QA oversight for packaging processes, artwork governance, and change management while leading and developing the Global Quality Supply team for consistent execution worldwide
• Establish QA governance for serialization and product traceability to meet regulatory requirements, ensuring data integrity and robust processes across CMOs, depots, logistics partners, and markets
• Provide QA oversight for late-stage development transitioning into commercial supply, managing change controls for packaging, labeling, serialization, and distribution
• Oversee QA governance for storage, transportation, and distribution, including cold chain management and shipping validation
• Ensure compliance with GDP, import/export regulations, and distribution licensing requirements within a harmonized global framework
• Manage incidents, deviations, investigations, and CAPAs related to packaging, serialization, storage, and distribution
• Support global recalls and critical supply incidents while driving proactive risk management and continuous improvement aligned with ICH Q9 and ICH Q10
• Collaborate with Supply Chain Management, Commercial Operations, Regulatory Affairs, and external partners (e.g., CMOs, packaging sites, depots, logistics providers) to define quality responsibilities and ensure accountability across the supply network through technical and quality agreements

Requirements

• Hold a degree in a relevant field (e.g., Pharmacy, Chemistry, Biotechnology, or related discipline)
• Bring 10+ years of pharmaceutical QA experience with a strong focus on commercial pharmaceutical supply (e.g., DSCSA, FMD)
• Demonstrate senior-level experience in commercial packaging, labeling, serialization, storage, and distribution quality, including partner oversight
• Apply deep knowledge of global regulatory requirements (e.g., FDA, EMA, WHO) and industry standards (GDP, GMP), with experience implementing and maintaining compliant quality frameworks
• Harmonize global processes while integrating country-specific requirements to enable efficient, unified strategies
• Identify, assess, and mitigate risks in supply chain and distribution processes, driving continuous improvement initiatives
• Lead global teams, drive cross-functional alignment, and make sound, risk-based decisions in complex environments
• Communicate effectively with internal and external stakeholders to align quality assurance efforts with broader business objectives

Benefits

• flexible hours
• vacation account
• Digital Learning
• Performance & talent development
• leadership development
• Apprenticeships
• LinkedIn Learning
• Company bike
• Job ticket
• Deutschlandticket
• Employer-funded pension
• Childcare