Senior Director, Quality Control
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Job Description
Sr Director, Quality Control managing end-to-end product quality of bladder cancer therapies at CG Oncology. Leading global quality strategy and oversight for clinical development through commercial launch.
Responsibilities:
- Establish and drive the global quality strategy aligned with corporate objectives, regulatory expectations, and risk-based approaches to product development and commercialization.
- Develop and lead quality strategy across the product lifecycle (clinical to commercial), ensuring operational excellence, phase-appropriate quality systems, and regulatory compliance.
- Represent Quality in strategic discussions and business planning across Technical Operations, Regulatory, and the Executive Leadership Team (ELT).
- Serve as quality SME for manufacturing campaigns, CMC strategy, and regulatory submissions (e.g., IND, BLA, supplements).
- Lead quality input for QTPP, CQA assessments, control strategies, stability programs, and product specifications.
Requirements:
- Bachelor’s or master’s degree in a life sciences discipline (e.g., Biology, Chemistry, Engineering)
- 10 years in biopharmaceutical Quality roles, including 5+ years in senior leadership
- Extensive experience in GxP, biologics manufacturing, late-stage development, and BLA-enabling activities
- Strong regulatory experience including authoring/reviewing submissions and representing company in global inspections
- Hands-on with product quality systems: CAPA, deviations, change control, batch release, comparability
- Demonstrated success working in matrixed environments
- High EQ and professional presence
- Up to 20% travel (domestic/international)
Benefits:
- Health (Medical, Dental, Vision) – PPO & HDHP – Cigna/Principal
- Health Spending Accounts - HSA (with Annual Company Contribution), FSA, FSA-DC
- Illness & Disability Protection – Company Paid LTD Coverage + Voluntary Plans
- Life Insurance – Company Paid 1 x base salary + Voluntary Plans
- 401K with 100% company Safe Harbor match up to 4% of base salary
- Unlimited Flexible Time Off
- Holidays – In 2026 we will observe 14 holidays
- Additional exclusive benefits – Voluntary Legal, Pet, Plus More
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