The Clinical Quality Assurance Auditor, within the Quality and Compliance Team, will report to the External Quality Manager. The QA Auditor will act as a GCP Subject Matter expert in guidance over audits and provide GCP support to both the clinical operations and clinical development teams. The individual will help to develop and maintain the Quality Management System through the development, implementation and maintenance of quality standards, policies, and procedures. This person will work within the Quality team to ensure compliance with FDA and other regulatory agency requirements, as well as supplier and internal company quality systems requirements.
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
Will serve as the main contact and SME, providing expertise in GCP compliance interpretation in support of QA oversight of clinical CROs, suppliers, and testing vendors
Collaborate with clinical operations, CRO vendors, testing sites and clinical depots to provide QA oversight while assessing compliance with regulations, clinical study protocols and SOPs.
Perform qualification audits of clinical suppliers
Work closely with external suppliers, clinical operations, and internal development teams to ensure project objectives are met in a compliant and timely manner
Track Quality documents and records (e.g. deviations, CAPAs, documents, audits, approved vendors) to ensure compliance with internal and external requirements
Work with Quality and Clinical Operations team members to develop, implement, and maintain a phase appropriate Quality Management System (QMS) through the creation, review and approval of documentation including policies and standard operating procedures (SOPs).
Investigate, triage, and document quality issues/deviations and recommend corrective actions/CAPAs related to clinical issues
Advise and assist Quality team members to maintain the internal and external audit programs
Participate in regulatory and partner audits
Assist in training new staff in quality system requirements and applicable regulations
Assist QA with other projects and tasks, where applicable (e.g. support of ongoing development and manufacture of Clinical Trial Material)
Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
BS or equivalent in life science or related field with 5+ years industry experience in Clinical Quality (GCP) with at least 1+ years of Quality Assurance experience; or equivalent education and experience
Knowledge of FDA regulations and standards, especially those pertaining to cell therapy, bioanalytical testing and clinical research
Quality certification such as ASQ/CQA
Additional prior experience in cGMP environment
Experience with Quality investigations
This position may require up to 15% domestic travel in the future, when company travel resumes
This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed.
Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com
Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission.We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
About Precision BioSciences
At Precision BioSciences, we utilize a proprietary genome editing method we call ARCUS combined with a team made up of some of the leading minds and pioneers in genome editing in an effort to overcome cancers, cure genetic diseases, and enable the development of safer, more productive food sources.