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SalaryJoin us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.
The Associate Director, Clinical Quality Assurance - Inspection Logistics and Training, provides critical leadership and oversight of the clinical quality compliance programs. The AD manages and controls the clinical vendor management program and the inspection preparedness program including TMF audits, investigator site audits, Risk-Based Quality Management, and the internal and external clinical compliance programs providing Good Clinical Practice (GCP) compliance oversight and guidance to multifunctional teams conducting clinical trials.
Primary Responsibilities / Duties:
- Manage Clinical Quality Assurance and oversee GCP compliance activities
- Oversee development and management of the Master Audit Plan for Clinical
- Ensure that the audit plan is implemented, to provide assurances that clinical research studies are of the highest quality standard and follow the requirements of SOPs, study protocols, relevant regulations and ICH/GCP and GCLP guidelines
- Contribute to inspection readiness planning, facilitating completion of inspection readiness tools, and inspection hosting and management.
- Ensure that audit results are formally and consistently recorded and reported, monitor trending and ensure that corrective/preventive actions have been requested and documented effectively
- Manage vendors and CROs during external and internal auditing
- Manage ICH/GCP Training at investigator meetings and internally
- Oversee the quality aspects of pharmacovigilance activities
- Develop and manage compliance budget and FTEs/consultants
- Oversee BIMO inspection preparedness
- Report KPIs to senior management on an ongoing basis
Requirements
Description
Education/Training
- Bachelor's degree in science, or equivalent degree/experience required
- 8+ years experience in QA required
ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.
