Manager of Internal Quality Assurance
- Employer
- Precision BioSciences, Inc.
- Location
- Durham, NC, United States
- Start date
- Sep 26, 2020
View more
- Discipline
- Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Bio NC
Job Details
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.
Company
Precision BioSciences, Inc. (Nasdaq: DTIL) is a clinical stage gene editing company developing in vivo gene editing and ex vivo allogeneic CAR T therapies with its highly precise and versatile ARCUS genome editing platform. ARCUS uses sequence-specific DNA-cutting enzymes, or nucleases designed for gene knock out, as well as highly sophisticated edits for gene insertion and/or gene repair. Precision’s in vivo gene editing pipeline consists of wholly-owned preclinical candidates for primary hyperoxaluria type 1 (PBGENE-PH1), familial hypercholesteremia (PBGENE-PCSK9) and chronic hepatitis B (PBGENE-HBV). It has also partnered with Lilly to develop candidates for Duchenne muscular dystrophy and two other programs targeting the liver and CNS. Precision’s allogeneic CAR T pipeline consists of multiple investigational candidates in early-stage clinical trials, including its first and second generation CD19 targeting candidates PBCAR0191 and PBCAR19B for relapsed and/or refractory (R/R) non-Hodgkin and B-cell lymphoma patients. Precision has also prioritized development of PBCAR269A, its BCMA targeted candidate in combination with a gamma secretase inhibitor for R/R patients with multiple myeloma. Precision BioSciences and its in-house manufacturing facility for AAV, mRNA, and CAR T cells is based in Durham, North Carolina. For more information about Precision BioSciences please visit www.precisionbiosciences.com
Stock Symbol: DTIL
Stock Exchange: NASDAQ
- Website
- http://www.precisionbiosciences.com/
- Phone
- 919-314-5512
- Location
-
302 East Pettigrew Street
Durham
North Carolina
27701
US
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert