Manager, Clinical Quality Assurance

Location
Durham, NC
Posted
May 09, 2022
Ref
2008036
Required Education
Bachelors Degree
Position Type
Full time

Summary

The Manager, Clinical Quality Assurance (QA), within the Quality and Compliance Team, will report to the Associate Director, External Quality and GxP Training. The Manager, Clinical QA will act as the Good Clinical Practices (GCP) Subject Matter Expert (SME) over audits and provide GCP support to both the Clinical Operations and 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.

**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.

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.

  • Serve as the main contact and SME for Clinical QA/GCP operations, providing expertise in compliance and interpretation in QA oversight of clinical contract research organizations (CROs), suppliers and testing vendors
  • Drive collaboration with Clinical Operations and Development groups to support successful and compliant execution of clinical trials and ensure project objectives are met in a compliant and timely manner
  • Work closely with internal teams, as well as CRO vendors, testing sites and clinical depots to provide Clinical QA/GCP oversight and assess compliance with regulations, clinical study protocols and other established procedures
  • Plan and perform qualification, study, system/process and eTMF audits of clinical CROs, suppliers, and vendors
  • Track and review Clinical QA/GCP documents and records (e.g., clinical study, electronic Trial Master File (eTMF), site audit documentation, vendor qualification, deviations, CAPAs) to ensure compliance with regulations and standards, as well as internal and external requirements
  • Investigate, triage and document quality issues/deviations, and recommend corrective actions/CAPAs related to clinical issues
  • Work with Quality and other internal 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).
  • 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

Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:

  • BS or equivalent in life science or related field with 8+ years industry experience in Clinical QA/GCP with at least 1+ years of Quality Assurance experience; or equivalent combination of education and experience
  • Knowledge of FDA regulations and standards, especially those pertaining to cell therapy, gene therapy, bioanalytical testing and clinical research
  • Clinical/GCP program QA oversight experience
  • Experience in planning and conducting clinical audits
Preferred:

  • Quality certification such as ASQ/CQA
  • Additional experience in GLP and/or GMP environments
  • Experience with Quality investigations

Travel Requirements

  • Occasional travel for audits and meetings is expected.

Location

· This is a hybrid position associated with the main headquarters in Durham, NC.

 

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.