Senior Director Protein Modality Lead(m/w/x)

Deine Aufgaben

• •Build and lead a data-driven team
• •Develop and implement a metric-driven leadership approach for protein-based products
• •Ensure alignment with risk management principles and regulatory guidelines
• •Provide leadership for protein-based products from a Quality Assurance perspective
• •Ensure phase-appropriate development while adhering to QMS and GMP standards
• •Oversee critical product changes related to regulatory compliance and quality
• •Guide changes across the product lifecycle for safety, efficacy, and manufacturing
• •Manage critical product deviations impacting compliance and quality
• •Lead thorough investigations and resolutions of product deviations
• •Communicate deviations to mitigate risks and maintain compliance
• •Foster a culture of collaboration and accountability within the team
• •Focus on team development and alignment with organizational priorities