Senior Manager of Technical QA (GMP)

Role: Senior Manager of Technical QA (GMP) overseeing quality compliance across Summit’s oncology biologics portfolio, supporting process validation, technology transfer, lifecycle management, and post-approval changes. Responsibilities: provide GMP oversight for clinical and commercial manufacturing, manage vendor quality performance, lead change control processes, review validation and comparability protocols, support regulatory submissions, and ensure audit readiness. Collaborate closely with MSAT, Technical Operations, Supplier Quality, and external partners to maintain compliance and drive continuous improvement. Requirements: Bachelor's in chemistry, biochemistry, chemical engineering, or related field; 10+ years in pharma with at least 5 years in biologics manufacturing, quality systems, and GMP compliance; experience managing CMOs and analytical labs; proficiency with regulatory filings (IND, BLA, MAA), and quality management systems like TrackWise; strong knowledge of FDA, EMA, ICH regulations. Preferred: advanced degrees (MS, PhD, PharmD), biologics experience, and international inspection support. High-Value: biologics, GMP manufacturing, process validation, change management, regulatory submissions, clinical to commercial lifecycle, global GMP compliance, US and international markets. Work Setup: on-site 4 days/week in Palo Alto, CA or Princeton, NJ.