Manager of Internal Quality Assurance

Location
Durham, NC, United States
Posted
Sep 26, 2020
Ref
1401910
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
The Manager of Internal Quality Assurance, within the Quality and Compliance Team, will report to the Vice President, Quality and Compliance. They will help to create 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 the FDA and other regulatory agency requirements, as well as customer and internal company quality systems requirements.

Essential Duties and Responsibilities
  • Act as the primary Quality Assurance contact for internal GMP operations. Assist with Quality Assurance oversight of other functions as required/assigned
  • Develop, implement, and maintain phase-appropriate Quality Management System (QMS) through the development, review and approval of documentation including policies and standard operating procedures (SOPs).
  • Create, revise, review, and approve documentation in Quality Assurance operations, including batch production records, protocols, investigations, change control, deviations, CAPAs and specifications
  • Perform internal and external audits independently, including planning, execution, report writing/issuance and CAPA approval/follow-up
  • Understand and interpret regulatory requirements and guidelines to ensure company compliance, and to maintain certification with regulatory authorities
  • Perform product and raw material receipt, review, and release
  • Train new staff in quality system requirements and applicable regulations
  • Manage and mentor junior Quality Assurance staff

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

Education/Experience
  • BS or equivalent in life science or related field with 10 years industry experience in GMP Quality Assurance, including experience in clinical phase Quality Assurance. Additional experience in GCP and/or GLP Quality Assurance a plus.
  • Demonstrated understanding of phase-appropriate compliance
  • Experience managing staff required
  • Knowledge of FDA regulations and standards, especially those pertaining to the production of biological products

Location
  • This is an office-based position at our Manufacturing Center for Advanced Therapies (MCAT) in the Research Triangle Park area in Durham, NC

Travel Requirements
  • This position requires little travel


Precision BioSciences is dedicated to improving life. Our mission is to cure genetic disease, overcome cancer, and feed the planet. We are achieving this with ARCUS, the first therapeutic-grade, naturally-derived genome editing system that uniquely combines the specificity and efficacy required to overcome lifes greatest genetic challenges. Learn more about the pioneers leading the next genetic revolution at: www.precisionbiosciences.com

Precision BioSciences provides 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.