Act as the primary point of contact for data-related queries within CMC, ensuring data definitions and access are clearly documented and maintained
Analyze existing business processes to identify inefficiencies and provide input on process improvement frameworks for strategic, transformation, and organizational enhancement initiatives, with a particular focus on data flows and data quality within CMC processes
Define and maintain data standards, data models and business rules for CMC Data Products, ensuring alignment with regulatory and business requirements
Work with IT to implement digital tools and solutions, including Data Products and data governance tooling, through conceptualization, creation, implementation and training to increase transparency and efficiency in collaboration
Facilitate communication and information flow between all relevant cross-functional stakeholders to support the change management process

Advanced academic degree (Master’s or PhD) in Life Sciences, Pharmacy, Chemistry, Engineering, or a related field
Relevant professional experience in the pharmaceutical or biotechnology industry, ideally with exposure to CMC, Technical Development, or Operations
Demonstrated expertise in process improvement, operational excellence, or organizational transformation initiatives
Solid understanding of CMC processes and the associated regulatory framework
Experience in digital transformation, including the implementation of data-driven or digital solutions; experience in data governance, data stewardship or Master Data Management is a strong plus
Familiarity with data governance frameworks, data quality principles, and metadata Management
Proven project management capabilities with a track record of delivering cross-functional initiatives
Experience in stakeholder management and cross-functional collaboration, including interaction with IT functions
Excellent communication skills, with the ability to convey complex concepts clearly and effectively
Fluency in English; German is considered an advantage

Associate Director, CMC Excellence & Strategy

Key skills