Sr. Consultant, Quality Assurance (Remote/Hybrid)

Cardiff Oncology is a clinical stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers. This opportunity is eligible for remote or hybrid work location. Position Summary: Cardiff Oncology is currently looking for a hands-on senior level Quality consultant to provide expert level guidance and support across the organization's clinical Quality functions. This consulting role provides expert level input to, and development of, strategic QMS and clinical QA-related plans designed to ensure patient safety, subject protection, and clinical data integrity following global GCP and GVP regulatory requirements and industry standards. This role will ensure Cardiff remains GCP/GVP compliant in accordance with all regulations and guidelines. Develop and oversee QA strategy, including risk assessment utilizing stakeholder and subject matter expert feedback, audit and inspection intelligence, industry trends, and other relevant data to assure adherence with relevant GxPs, Cardiff policies and procedures, relevant local laws, regulations, and best practices Lead QA activities, including assessments and audits, as well as QA functional oversight Establish vendor qualification and audit programs and oversee contract research organizations (CROs), clinical investigator sites, central/specialty laboratories, and other clinical service providers Design and implement internal compliance controls via audits and assessments that follow a risk-based approach as described and supported by the applicable global regulatory health authorities Oversee QMS documentation, audit programs, quality event-related QA activities, QMS/regulatory training, vendor qualification, etc. Develop GCP/GVP audit programs, including comprehensive clinical QA audit and inspection activities (investigator sites, CROs, vendors, and clinical study documentation), risk mitigation to assure the appropriateness and effectiveness of the audit programs, processes, and activities, such that they assure that company clinical activities are compliant with relevant global and local procedures and regulations Provide oversight of all outsourced QA activities, serving as internal point of contact Contribute to regulatory strategy and serve as QA SME in meetings with regulators Assist with the management all GxP audits and inspections by FDA and other applicable health authorities. Provide quality oversight of clinical trial conduct, including protocol compliance, informed consent, and subject safety reporting, and partner with Clinical Operations and Pharmacovigilance to ensure GCP/GVP compliance Perform timely review of clinical documentation, investigations, and reports highlighting and assisting in the resolution of issues commensurate with the level of risk Ensure clinical programs meet the quality and data-integrity standards required to support successful regulatory submissions, including U.S. NDA/BLA and EU MAA filings, and provide QA oversight of clinical data and documentation in preparation for marketing applications and health authority review Partner cross-functionally with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Data Management to embed a culture of quality and drive timely, risk-based resolution of clinical quality issues Minimum Qualifications: Bachelor’s degree in a healthcare or life sciences discipline required and 12 years combined experience in Quality Assurance with significant expertise in clinical quality (GCP and GVP); GLP and GMP exposure a plus Master’s or PhD preferred Must possess a deep understanding of Quality Assurance principles, industry practices, and standards with demonstrated ability to apply these to GxP operations Experience in Oncology highly desirable Demonstrated expert knowledge of GxP global health authority requirements, guidance, and expectations, including FDA, EMA, ICH, and MHRA Excellent understanding of QMS concepts and processes, and how auditing and other QA activities support the growth and maturity of the system Demonstrated knowledge of clinical QA audits (investigator sites, CROs, and clinical vendors) and strong auditing skills and experience with regulatory inspections, ideally at a global level Ability to influence and negotiate with internal and external stakeholders to promote positive interactions and successful relationships with proven success implementing procedures and effective change management Proficiency in written communication and meticulous attention to detail in editing Previous experience working in a small pharma or biotech company is highly desirable The consulting rate for this role will be between $100 - $150 per hour. Actual compensation will be dependent upon the individual's skills, experience, qualifications and location. This is a consultant role and will not be eligible for benefits. This opportunity is eligible for remote or hybrid work location. #J-18808-Ljbffr Cardiff Oncology