Vice President, Analytical Development & Quality Control

CG Oncology

5h•Remote

About The Position

CG Oncology is seeking a Vice President of Analytical Development and Quality Control (VP, AD & QC) to provide strategic and operational leadership across analytical development, quality control, and related compliance activities supporting late-stage clinical development, BLA submission, and commercial readiness. This role is critical to ensuring robust, phase-appropriate analytical strategies, compliant QC operations, and seamless cross-functional collaboration as CG Oncology advances toward commercial launch. The VP, AD & QC will serve as a key member of the Technical Operations leadership team, partnering closely with CMC, Manufacturing, Regulatory Affairs, Quality Assurance, Clinical Development, and external partners to deliver high-quality, compliant analytical systems that support product lifecycle management. Location: Remote

Requirements

PhD or MS in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related discipline.
15+ years of experience in analytical development and/or quality control in biotech or pharma.
Experience supporting late-stage clinical programs, BLA submissions, and commercial readiness.
Deep knowledge of GMP, ICH guidelines, and global regulatory expectations.
Proven experience leading and scaling analytical and QC organizations

Responsibilities

Serve as a strategic partner with the Tech Ops and CMC leadership to define regulatory strategies.
Bring hands-on experience to author regulatory submissions within US and Ex-US, coaching and guiding AD/QC staff to author reg submissions.
Work with Tech ops senior leadership to define, develop and execute CGO’s post commercial pathway.
Build sustainable and appropriate organization structure to support CGO future growth from late stage company to a commercial and growing company.
Define and execute the global analytical development strategy across all stages of development, from late-stage clinical through commercial lifecycle management.
Ensure analytical methods are scientifically sound, phase-appropriate, robust, and aligned with regulatory expectations.
Oversee method development, qualification, validation, transfer, and lifecycle management for drug substance and drug product.
Lead and scale Quality Control operations, including in-house and external QC testing activities.
Ensure QC systems meet GMP requirements and remain inspection-ready.
Support regulatory submissions and serve as an analytical SME for health authority interactions.
Build, lead, and mentor a high-performing Analytical Development and Quality Control organization.
Manage external laboratories, CROs, CDMOs, and testing partners.
Collaborate cross-functionally to support tech transfer and commercialization readiness.
Representing QC/AD during our interactions with regulatory authorities and leading RI/meetings.
Heading all the operations related to QC for commercial manufacturing including batch release, stability studies.
Authoring multiple on-going submissions to Regulatory agencies including INDa, BLA, sBLA, comparability reports
Identifying current gaps in the QC/AD organization and restructure or building it to address CGO needs while growing staff.
Establish a collaborative environment within Tech Ops and its internal and external facing organizations including but not limited to QA, DS and DP group, supply chain, clinical ops/Dev and our analytical testing vendors.