A leading oncology organization is looking for a Director of Clinical QA to join their team. Just like the company, this candidate will be a visionary of the future of the oncology areas through the clinical trails for the organization and it's partners. Take a look!
Principle Responsibilities and Duties:
- Develops and executes a quality governance and oversight program of clinical vendors and monitors vendor quality performance metrics.
- Consults with other R&D functions in developing appropriate vendor quality oversight and inspection preparation plans. Conduct or make assignments for audits (on-site and/or remote) of Clinical Service Providers (e.g. Laboratories, Phase I Units/Clinical Pharmacology Units (CPUs), Bioanalytical Laboratories, Clinical Investigator sites and internal processes.) Review and evaluate key clinical system validation/qualification packages for completeness, accuracy, and compliance with company and relevant Regulatory requirements.
- Mentor other Clinical Quality Operations Quality personnel and contractors; may have supervisory responsibilities within Quality Assurance Unit.
- Conduct or lead GCP, GLP, GCLP, and GPVP training and education in accordance with global GCP standards.
- Develop risk-based recommendations for prioritization of risks and appropriate corrective/preventative actions.
- Author, revise, and implement CQA written procedures.
- Drive preparation activities for GCP, GLP, GCLP, and GVP Health Authority inspections to assure successful outcomes of the inspections from conduct through the coordination of responses.
- Ensure follow-up on all inspection commitments, post-inspection activities, corrective, and preventative actions, and resolve all conflicts for timely closure.
- Directly interface with Clinical Development, Clinical Operations, Translational and Development, Pharmacovigilance, and other supporting areas for GCP audits of internal processes.
- Promote collaboration to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
- Ensures appropriate corrective and preventive actions (CAPAs) are completed in a timely manner. As appropriate escalates issues of critical noncompliance and/or lack of urgency in remediation to senior management and appropriate internal R&D functions.
Qualifications
- BS degree in a scientific field.
- 12 years or greater experience in a Biotechnology/Pharmaceutical CQA role with at least 10 years CQA auditing experience.
- Strong knowledge of global GCP, GLP, GCLP, and GPVP regulations and standards.
- Experience with Health Authority Inspections
- Expert knowledge of regulatory authority inspection practices internally, externally, domestic, and internationally
- Extensive experience managing and supporting regulatory authority inspections of clinical research activities.
- Extensive leadership experience and mentoring skills to ensure all team members have a firm understanding of inspection process.
- Thorough knowledge and application of international requirements of GCP, GLP, GCLP, GVP, and relevant ICH Guidelines
