Senior Director Protein Modality Lead

• Build and lead a data-driven team under a target operating model for protein-based products, ensuring alignment with risk management principles and regulatory guidelines
• Provide leadership for all protein-based products from a Quality Assurance perspective, ensuring phase-appropriate development while maintaining adherence to QMS and GMP standards
• Oversee and guide critical product changes related to regulatory compliance, quality, safety, efficacy, manufacturing sites, technology transfers, and commercial preparations and launches
• Lead and manage critical product deviations with potential impacts on regulatory compliance, quality, safety, efficacy, manufacturing sites, technology transfers, and commercial preparations and launches

Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

• A degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related field (advanced degrees like MSc, PhD, MBA are highly desirable)
• Extensive experience in R&D Quality or Product Quality with proven track record of leading through product challenges related to compliance, quality, and product launches
• Deep understanding of ICH guidelines (Q8, Q9, Q10) and their application in protein product development and lifecycle management
• Proven ability to lead and develop teams, fostering a culture of collaboration and accountability while driving operational excellence

• Flexibility: flexible hours, vacation account
• Growth opportunities: Digital Learning, Performance & talent development, leadership development, Apprenticeships, LinkedIn Learning
• Value: Your voice at the table, Culture on an equal footing, Opportunities to shape & impact, Support for your full potential
• Health and lifestyle: Company bike
• Mobility: Job ticket, Deutschlandticket
• Life phases: Employer-funded pension, Childcare