Product Quality Associate Director

Job Summary

Seeking a remote full-time Product Quality Associate Director, this role will provide technical expertise and leadership within the Product Quality Team, engaging with various departments on product filings, program improvements, and investigations related to product quality for late-stage or commercial biologics products.

Key responsibilities:

• Ensure Product Quality deliverables are defined and prioritized within timelines across the Product Delivery Team
• Coordinate discussions and lead decision-making for strategies and activities supported within the Product Quality Team
• Provide subject matter expertise and strategic influence for science and risk-based evaluations of complex process and product quality data

Required qualifications:

• Doctorate degree with 3 years of relevant experience, or a Master's degree with 5 years, or a Bachelor's degree with 7 years, or an Associate's degree with 12 years, or a high school diploma/GED with 14 years of relevant experience
• Experience in a regulated environment with biologic products
• Proficiency in knowledge of cGMP and international regulatory expectations
• Experience with authoring or reviewing regulatory documentation such as market applications or INDs
• Strong scientific data management and organization skills