Senior Director, Quality Control
San Diego, San Diego County, California, 92189, USA
Listed on 2026-10-09
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Role:
Senior Director of Quality Control overseeing product quality and compliance across CG Oncology’s bladder cancer therapies from clinical to commercial phases.
Responsibilities: establish and lead global quality strategies, ensure regulatory and GxP adherence, oversee analytical and manufacturing quality systems, support process validation and technology transfer, lead CAPA and risk management initiatives, and build/mentor QC teams.
Requirements:
Bachelor's or Master’s in Life Sciences; 10+ years in biopharma quality roles, including 5+ years in senior leadership; extensive GxP experience with biologics development, late-stage manufacturing, and regulatory submissions; hands‑on expertise with quality systems such as batch release, deviations, and change control; proven leadership in matrix environments.
Preferred: experience in biologics manufacturing, BLA submissions, and global inspection readiness; strong regulatory engagement skills; up to 20% travel.
High Value: biologics, biologics manufacturing, late-stage development, BLA, GxP, product lifecycle oversight, regulatory compliance, international collaboration, remote work option.
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