Sr Director, Quality Control

CG Oncology

7h•$230,000 - $270,000•Remote

About The Position

The Sr Director, Quality Control at CG Oncology reports to the VP, Analytical Development and Quality Control and serves as a strategic leader responsible for end-to-end product quality and quality control oversight across the product lifecycle—from clinical development through commercial launch and building commercial Quality Control capabilities—of CG Oncology’s bladder cancer therapies. This role ensures product quality, regulatory alignment, and operational excellence through robust quality systems, analytical quality oversight, product release governance, strategic quality planning, and cross-functional coordination. The Sr Director, Quality Control will help shape the quality vision and execution plan in alignment with CG Oncology’s mission and compliance standards, while partnering closely with Technical Operations, Regulatory Affairs, and executive leadership.

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
Familiarity with startup biotech operations and the ability to flex between strategic and tactical needs

Nice To Haves

Up to 20% travel (domestic/international)

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.
Direct strategic oversight of assay validation, raw materials qualification, reference standards, comparability assessments, and analytical bridging documentation.
Provide strategic oversight of product release activities, including batch record review, lot disposition support, deviation escalation, and product impact assessments for clinical and commercial materials.
Lead oversight of QC testing programs including in-process, release, stability, environmental monitoring, and raw material testing to ensure compliant and reliable product quality outcomes.
Ensure robust governance of Out-of-Specification (OOS), Out-of-Trend (OOT), invalid assay, and laboratory investigation processes, including escalation, root cause analysis, and effectiveness monitoring.
Establish and maintain product quality review processes, including Annual Product Reviews (APR/PQR), trend analysis, complaint trending, and ongoing process verification activities.
Ensure analytical methods, specifications, and product control strategies remain phase appropriate, inspection-ready, and aligned with evolving regulatory expectations.
Partner with Technical Operations leadership team, AD, and CDMOs to ensure quality-compliant and phase-appropriate manufacturing processes and analytical methods.
Provide guidance for validation activities (e.g., assay/process validation, tech transfers, PPQ) to support launch-readiness and lifecycle management.
Ensure the integrity, reliability, and traceability of quality data reporting to leadership and regulatory bodies.
Partner closely with Analytical Development, Manufacturing Sciences & Technology (MSAT), and CDMOs to ensure assay reliability, testing robustness, and product release readiness.
Oversee implementation and continuous improvement of product quality metrics, including deviation rates, CAPA effectiveness, right-first-time performance, assay variability, and lot acceptance trends.
Provide quality leadership during technology transfer, process characterization, PPQ campaigns, and commercial launch activities with emphasis on product quality consistency and control.
Ensure data integrity, ALCOA+ compliance, and inspection readiness across laboratory systems, analytical data management platforms, and product quality records.
Lead quality risk management initiatives, including root cause investigations, CAPAs, and change control in collaboration with QA.
Establish and improve systems and analytics to support audit readiness, inspection outcomes, and proactive compliance.
Drive operational efficiency and culture of continuous improvement across product quality systems and cross-functional teams.
Lead cross-functional product quality governance forums to proactively identify emerging quality risks, product trends, and compliance gaps across internal and external manufacturing networks.
Drive implementation of advanced quality analytics and risk-based monitoring tools to improve product quality visibility, predictability, and decision-making.
Establish proactive product quality surveillance programs to monitor process capability, assay performance, complaint trends, and stability outcomes throughout the product lifecycle.
Serve as a key Quality leader in cross-functional teams (CMC, Tech Ops, Regulatory) to assess and influence external manufacturing and supply strategies.
Build, mentor, and manage a high-performing quality team aligned with CG Oncology values and performance culture.
Represent Quality during regulatory inspections, executive updates, and industry forums.