CG Oncology logo
CG Oncology

Attacking Bladder Cancer for a Better Tomorrow

Senior Director, Quality Control

DirectorDirectorFull TimeRemoteSeniorTeam 11-50Since 2010H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

21 days ago

Salary

$230K - $270K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

Senior Director, Quality Control

CG Oncology

• 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.

Job 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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