Senior Director, Quality Control

CG Oncology

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.

Posted 5/30/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $230,000 - $270,000 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

quality strategyregulatory complianceGxPbiologics manufacturingBLA-enabling activitiesCAPAdeviationschange controlbatch releasecomparability

Soft Skills

leadershipinterpersonal skillshigh EQprofessional presenceoperational excellencestrategic thinkingcollaborationcommunicationmatrixed environment experiencebusiness planning

Industry Keywords

life sciencesclinical to commercialquality systemsregulatory submissionsINDBLAQTPPCQA assessmentsstability programsproduct specifications

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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