CG Oncology

QA Engineer

• The Senior Specialist, Quality Assurance – Drug Product is responsible for executing quality assurance activities that support clinical and commercial manufacturing operations in compliance with cGMP standards.
• This role focuses on batch record review, vendor oversight, and ensuring the accuracy and completeness of GMP documentation across internal and external manufacturing operations.
• The individual will work closely with contract manufacturers to support tech transfer, process validation, and routine GMP operations.
• Success in this role requires strong attention to detail, the ability to manage multiple priorities, and effective cross functional collaboration to ensure timely batch disposition and compliance.
• The position serves as a key contributor within the QA team, supporting inspection readiness and the ongoing operation and continuous improvement of the GMP Quality System, while also providing occasional support for clinical labeling, drug substance contract manufacturing, and other QA activities as needed.

Senior Specialist, Quality Assurance – Drug Product

Director

• Guide Study Design and Execution of Clinical Trials
• Provide statistical leadership and oversight for Phase 1-3 clinical trials.
• Contribute to and lead statistical aspects of study design activities including endpoint selection, sample size determination, randomization strategies, interim analyses, and statistical methodologies.
• Partner with Clinical Development and Clinical Operations to ensure study objectives, statistical assumptions, and operational execution are aligned.
• Review and provide input on protocols, protocol amendments, study conduct, and trial execution to ensure scientific rigor and regulatory acceptability.
• Support Data Monitoring Committees (DMCs), Safety Review Committees, and other governance bodies as needed.
• Author/Review Regulatory Documents and Support Regulatory Strategies
• Lead or contribute to the development and review of SAPs, protocols, CSRs, and regulatory submission documents.
• Support statistical contributions to regulatory interactions, including preparation for meetings with FDA and international health authorities.
• Contribute to regulatory strategy by ensuring statistical approaches align with applicable regulatory guidance and expectations.
• Support preparation of responses to regulatory questions, information requests, and health authority meetings.
• Ensure statistical deliverables meet quality, compliance, and submission readiness standards.
• Data Interpretation and Support Decision Making
• Interpret and communicate clinical trial results to cross-functional teams and functional leadership.
• Translate complex statistical findings into clear, actionable insights that inform development strategy and business decisions.
• Contribute statistical input into benefit-risk assessments, program evaluations, and clinical development planning.
• Support publication strategies, scientific presentations, and external communications by ensuring accurate interpretation of statistical results.
• Present statistical analyses and recommendations to cross-functional teams and governance committees.
• Process Improvements
• Identify opportunities to enhance efficiency, quality, and consistency across biostatistical processes and deliverables.
• Contribute to the development and implementation of standards, templates, and best practices.
• Promote innovative statistical methodologies, data visualization approaches, and analytical tools.
• Contribute to inspection readiness initiatives and continuous improvement of quality systems.
• Promote statistical integrity, reproducibility, and compliance with industry and regulatory standards.
• Oversee CROs and External Partners
• Provide oversight and management of CRO statisticians, statistical programmers, and other external vendors.
• Review and QC vendor deliverables to ensure quality, scientific accuracy, regulatory compliance, and adherence to timelines.
• Establish expectations, monitor performance, and proactively manage risks related to outsourced statistical activities.
• Serve as a key statistical representative for external partners and ensure alignment with program objectives.
• Support vendor selection, budgeting, and resource planning activities as needed.
• Mentor Team Members
• Provide technical guidance, coaching, and mentorship to statisticians and cross-functional team members.
• Foster a culture of collaboration, accountability, scientific excellence, and continuous learning.
• Support talent development through training, knowledge sharing, and professional growth opportunities.
• Support departmental resource planning and knowledge-sharing initiatives.
• Serve as a role model for leadership, collaboration, and effective communication across the organization.

Associate Director – Biostatistics

Software Engineer

• Provide technical leadership for statistical programming activities across multiple clinical development programs
• Lead the development, validation, and maintenance of SDTM and ADaM in accordance with CDISC standards and regulatory requirements
• Oversee creation and maintenance of specifications, Define.xml packages, and submission-ready deliverables
• Ensure programming deliverables support study objectives, statistical analyses, and regulatory submission requirements
• Serve as the programming subject matter expert for complex analyses, integrated summaries, and submission activities
• Develop and review analysis datasets, tables, listings, figures (TLFs), patient profiles, and ad hoc analyses
• Ensure programming deliverables meet quality, traceability, reproducibility, and regulatory compliance standards
• Establish and maintain programming specifications, validation plans, and quality control procedures
• Lead implementation and governance of SDTM, ADaM, and Define.xml standards across development programs
• Evaluate evolving industry standards and regulatory guidance and implement best practices within the organization
• Drive continuous improvement initiatives across statistical programming processes and systems
• Review vendor deliverables for quality, consistency, regulatory compliance, and adherence to timelines
• Mentor and develop team members, leading training initiatives related to CDISC standards, programming methodologies, validation practices, and submission requirements

Senior Principal Programmer

• 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.

Senior Director, Quality Control

• Support the implementation, revision, and maintenance of QA programs, policies, and procedures to ensure compliance with cGMP, FDA, and ICH requirements.
• Assist in updating SOPs to mitigate compliance gaps and support commercial QA readiness.
• Support QA activities related to drug substance tech transfer, process performance qualification (PPQ), and preparation for process validation activities.
• Ensure QA compliance of validation protocols, reports, and associated GMP documentation during execution.
• Perform QA review of batch production records, validation data, deviation investigations, and analytical documentation associated with drug substance manufacturing to ensure accuracy, completeness, and compliance with GMP standards.
• Support timely disposition activities once all required data is available.
• Serve as a QA point of contact for assigned contract manufacturers and partners by supporting QA oversight activities.
• Support and participate in GMP audits for vendor qualification or requalification (minimum of two), including preparation, execution support, and documentation of findings.
• Perform QA review of manufacturing, validation, and analytical documents related to API/drug substance release testing, stability programs, raw materials, intermediates, and analytical method qualification/validation to ensure compliance with regulatory expectations.
• Support the review and resolution of quality system events, including deviations, CAPAs, change controls, and out-of-specification investigations.

Senior Specialist, Quality Assurance – Drug Substance

Manager

• Provide IT-owned support and administration for assigned Commercial enterprise systems across Patient Access, Market Access, Sales Operations, Sales, Communications & Patient Advocacy, Marketing, Business Analytics & Operations, Strategy & Business Operations and related Commercial business processes.
• Provide sustainable operational support for Commercial systems such as CRM, data warehouse, EDI, Master Data Management, Alignment, Call Plans, IC, marketing technologies, etc.
• Log, track, prioritize, and resolve system administration requests, incidents, and service tickets, ensuring timely resolution, appropriate escalation, adherence to defined SLAs, and ongoing ownership, maintenance, and operational excellence.
• Act as a bridge across Commercial and enterprise data domains, partnering with Finance, Compliance, HR, and other functions to reinforce a single, governed, and scalable enterprise data foundation.
• Leverage the existing data warehouse as a system of record, improve connectivity and data flow across platforms, and prevent the creation of parallel or fragmented data environments through standardization and integration discipline.
• Manage back-end system administration activities, including user access, role assignments, permissions, workflows, configuration updates, support tickets, and system maintenance.
• Serve as an IT point of contact for assigned Commercial applications, ensuring systems are supported in a compliant, secure, scalable, and business-aligned manner.
• Support system availability, issue triage, troubleshooting, escalation, and resolution in partnership with vendors, IT, and functional business owners.
• Accountable for overall health, compliance posture, and performance of assigned Commercial systems throughout their lifecycle.

Senior Manager, IT Business Partner – Commercial Systems

• Support the development, improvement, and management of QA programs, policies, and procedures to ensure cGMP compliance.
• Serve as the QA contact for specified vendors, contract facilities, or joint development collaborators.
• Perform QA review of manufacturing records, validation related records, batch records, and documents submitted to regulatory agencies.
• Lead cGMP auditing of vendors.
• Provide input on the vendor’s Quality System events, including change control, deviations, investigation, out-of-specifications, and CAPAs.

Manager, Commercial Quality Assurance

• Provide technical and operational leadership across all aspects of drug product development and manufacturing for small molecule and/or viral products, including formulation, fill-finish, and clinical in use studies.
• Contribute to regulatory strategy for late-stage and commercial programs, ensuring alignment with current guidances and global expectations.
• Author and review drug product sections of regulatory filings, including BLA and responses to health authority information requests.
• Partner closely with drug substance, analytical development, quality assurance, quality control, supply chain, and regulatory groups to ensure alignment across CMC activities.
• Support management of external manufacturing sites in collaboration with technical SMEs to ensure aligned decision-making and smooth execution.
• Provide technical guidance on post-approval changes and lifecycle management strategies.
• Provide leadership by aligning priorities, developing talent, and empowering teams to deliver outcomes independently.