Associate Director, Analytical Development & QC

Role: Associate Director of Quality Control overseeing QC testing for drug substance, drug product, and stability programs in late-stage and commercial oncology development. Responsibilities include managing vendor relationships, method transfers, validations, and data oversight; leading investigations and handling GMP deviations; authoring QC documentation; and ensuring compliance with global regulatory standards. Collaborates with cross-functional teams such as CMC Regulatory Affairs, Quality Assurance, and supply chain to meet project milestones. Mentors team members and drives continuous improvement initiatives. Requirements: Bachelor's degree in a scientific discipline with 15+ years of experience in pharmaceutical QC operations across development and commercial stages; strong knowledge of cGMP, FDA, EU, ICH guidelines, and global regulatory submissions (IND, NDA, MAA); extensive experience with small molecules and biologics manufacturing, testing, and validation. Preferred skills include excellent communication, problem-solving, and the ability to work independently in a fast-paced environment. High-value biopharma specifics: late-phase and commercial QC, biologics experience preferred, global regulatory knowledge, emphasis on process validation, release testing, and inspection readiness. Work setup: onsite at Redwood City, CA, with a salary range of $186,000-$233,000.