Milford, MA – Prestige Scientific is excited to announce the successfully completed search for a Senior Director of CMC Quality Assurance for our partner, a late-stage clinical biotechnology company that focuses on developing transformative medicines to address life-altering autoimmune and inflammatory diseases.
The individual hired for this role has extensive experience in quality assurance and external manufacturing oversight within the pharmaceutical and biotech industries. They have successfully led initiatives to enhance QA systems, streamline compliance processes, and prepare organizations for regulatory inspections. Their expertise includes managing vendor relationships, implementing KPIs to improve quality performance, transitioning systems to global digital platforms, and ensuring adherence to FDA and EMA regulations. With a strong background in biologics and technical operations, this individual is skilled at resolving critical quality issues, developing strategic inspection plans, and fostering productive stakeholder collaborations.
This critical hire will lead the CMC QA team to establish and implement comprehensive GMP policies and procedures, ensuring robust quality assurance support throughout the product lifecycle from early development to commercial launch. This individual will oversee all quality-related activities, including manufacturing, testing, and vendor oversight, to maintain compliance with cGMP, ICH, and regulatory standards while optimizing efficiency in R&D and manufacturing operations. They will utilize their expertise to work cross-functionally with program teams and corporate leadership to align quality objectives with strategic goals, mentor team members, and foster a culture of collaboration, transparency, and continuous improvement.
Prestige presented 16 highly qualified QA professionals for this role, the hired candidate was presented 16 days from the start of the search, and the search was completed in 48 days. Congratulations to our Quality search team for this successful project!
About Prestige Scientific:
Prestige Scientific is an executive search firm that advises our clients on recruiting impactful leaders. We provide our clients with a performance-based hiring system that identifies leaders with past success meeting similar corporate objectives as their own, while overcoming challenges and adhering to critical timelines. We have dedicated experts in eleven practice areas that mirror a typical biopharma company, allowing us to support our client's growth from Discovery through Commercial.
