Senior Manager, QA - Commercial GMP

CG Oncology

1d•Remote

About The Position

The Senior Manager, QA – Commercial GMP is responsible for leading and executing Quality Assurance oversight for commercial-and clinical stage drug product operations, ensuring sustained GMP compliance across internal manufacturing activities and external contract manufacturing organizations. The position serves as the primary QA partner for drug product lifecycle management, including commercial production, technical transfers, change management, deviation management, and inspection readiness. Success in this role requires balancing hands-on QA execution with strategic oversight, cross-functional influence, and regulatory judgment in a fast-moving environment. The individual will work closely with Technical Operations (Manufacturing and Quality Control), Supply Chain, Regulatory Affairs, and external contractors to ensure product quality and patient safety. As part of the Commercial GMP QA leadership team, this role is expected to contribute to continuous improvement initiatives and help scale quality systems to support future growth. Many routine quality monitoring, documentation review, and trend analysis activities are increasingly supported by digital quality systems and AI-enabled analytics, requiring the individual to effectively integrate technology into day-to-day QA decision-making.

Requirements

BS/BA in a relevant scientific discipline
At least ten (10) years of experience in Quality Systems and Quality Assurance processes, including development and documentation.
Minimum of two (2) years in a managerial role, including supervisory experience of QA personnel
Experience with commercial and clinical drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry.
Comprehensive knowledge of GMP regulations, ICH, and FDA guidelines critical to sterile product manufacture of biologics.
Conduct investigations, risk assessments, complete GMP QA related forms, etc.
Five (5) years of experience in Quality Systems and Drug Product Quality Assurance, particularly in the biotech or pharmaceutical industry.
Experience with Drug Product Process Performance Qualification leading towards commercialization.
Experience with analytical method qualification/validation.
Experience as a QA Manager, including supervisory responsibilities

Responsibilities

Provide day-to-day Quality Assurance support for commercial and clinical drug product manufacturing activities, including review and approval of batch records, deviations, investigations, change controls, and CAPAs, ensuring decisions are scientifically sound and compliant with GMP requirements. Performance will be evaluated based on quality of documentation, timeliness of reviews, and effectiveness of corrective actions.
Serve as the primary QA liaison for assigned contract manufacturing organizations, overseeing quality agreements, performance monitoring, issue resolution and escalation, and continuous improvement activities. This includes conducting and supporting audits, evaluating quality metrics, and ensuring alignment with internal quality expectations. Success will be measured by successful resolution of issues and timely escalation of critical issues to management.
Support drug product lifecycle activities, including technical transfers, process changes, validation activities, and stability programs, by providing proactive QA input and risk-based decision-making. Effectiveness will be demonstrated by smooth execution of changes with minimal quality disruptions.
Lead or support internal and external audits and inspections related to drug product operations, including preparation, execution, response development, and follow-up actions. Performance will be assessed based on inspection outcomes, quality of responses, and timely closure of commitments.
Contribute to the continuous improvement of the Quality Management System by identifying trends, recurring issues, and opportunities to strengthen processes, training, and documentation. Success will be measured by measurable improvements in quality metrics and inspection readiness indicators.
Provide mentorship, guidance, and informal leadership to QA colleagues and cross-functional partners, helping to build a strong quality culture across commercial operations. Effectiveness will be reflected in stakeholder feedback, team capability development, and consistent application of quality standards.