Director,BiologicsDevelopmentOperationalQuality

**Job Description** **Summary:** The Director Biologics Operational Development Quality is responsible for oversight of development Quality team activities, technical development of personnel and ensuring the quality of deliverables. The incumbent is responsible for creation, development and maintenance of relationships with CMO Quality managers and professionals as well as internal stakeholders. The incumbent is known for technical expertise and assists with the strategic alignment of group and department goals with its projects and activities, refining and adapting as necessary through proactive monitoring/measurement. The role will be responsible for working with internal and external stakeholders in a matrix environment; Influencing/building/promoting a culture of Quality and to meet business, quality and regulatory objectives. **Key Duties & Responsibilities** * Provide strategic quality and compliance guidance across biologics development, manufacturing, and clinical supply to ensure alignment with global regulatory expectations * Lead the implementation and continuous improvement of Quality Management Systems (QMS) supporting development and manufacturing operations. * Establish and oversee risk management frameworks to proactively identify, assess, and mitigate quality and compliance risks across programs. * Provide quality oversight of internal operations and external partners (e.g., CMOs, CROs), including supplier qualification, performance management, and technical transfer activities. * Partner with cross-functional stakeholders (e.g., Manufacturing, Regulatory, Technical Development) to support program execution, regulatory submissions, and inspection readiness. * Drive inspection readiness and lead or support regulatory inspections, audits, and responses to health authority inquiries. * Oversee key quality processes including batch disposition, deviations, investigations, change control, and CAPA to ensure compliance and consistency. * Support developm