Sr. Consultant, Quality Assurance (Remote/Hybrid) Full Time NEW

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 all Quality functions for the organization. This consulting role provides expert level input to, and development of, strategic QMs and QA-related plans designed to ensure patient safety and data integrity following global GxP regulatory requirements and industry standards. This role will ensure Cardiff remains GxP compliant in accordance with all regulations and guidelines.

Essential Job Responsibilities:

• 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 supplier qualification and audit programs and oversee contract manufacturing organizations (CMOs), contract laboratories, and external vendors
• 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 GxP audit programs, including comprehensive QA audit and inspection activities, risk mitigation to assure the appropriateness and effectiveness of the audit programs, processes, and activities, such that they assure that company operational activities are compliant with relevant global and local procedures and regulations
• Oversee and support QA audit programs and plans executed by internal QA staff or contracted auditors
• 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
• Provide expert GxP guidance to all functions across the company
• Assist with the management all GxP audits and inspections by FDA and other applicable health authorities.
• Perform timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
• Oversee Quality System procedures to ensure compliance with applicable GxP laws and regulations and drive systemic improvements

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 GMP, GCP, and GLP
• 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 QA audits and strong auditing skills and experience with 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.