Director, Product Quality

Quality Oversight:

• Lead end-to-end technical quality oversight for drug substance and drug product CMOs.
• Conduct science- and risk-based evaluation of product and process data to ensure patient-centric, compliant solutions.
• Lead major investigations, change controls, and CAPAs impacting product quality.

Quality Strategy:

• Develop and implement comprehensive product quality strategies, including specifications, control strategies, and comparability assessments.
• Advise on commercialization strategies, including in-process controls, stability, and lifecycle management.
• Ensure timely execution of product quality activities such as APQRs, specification justifications, and risk assessments.

Regulatory Support:

• Support regulatory submissions and serve as Quality lead for responses to regulatory inquiries.
• Demonstrate deep knowledge of cGMP and international regulatory expectations for biologics or cell therapy products.
• Utilize excellent communication skills, including experience with regulatory submissions and cross-functional presentations.