Reporting to the Associate Director of Quality Control, the Quality Control Manager will oversee Quality Control activities in support of GMP manufacturing programs. The individual will manage a team to support externally sourced projects, internal testing, quality events, and documentation related to the assigned contract organizations. The individual will act as interdepartmental liaison to various groups, including Analytical Development, Manufacturing Quality Assurance, and Regulatory Affairs.
- Manage product testing activities at contact manufacturing organizations/labs
- Coach and mentor staff in all aspects of their job performance and career development
- Manage routine activities conducted by the Quality Control function
- Develop/maintain departmental reference standard program, QC processes and procedures
- Drive Change Controls, Deviations, and CAPAs from initiation to completion
- Represent Quality Control on cross-functional project teams
- Support GMP audits of contract testing sites
- Author/review relevant sections of regulatory submission documents
- Assist with development and maintenance of departmental budget
- Bachelor’s degree in a scientific field with a minimum of 8+ years of experience in a GMP laboratory, with a minimum of 5+ years of team leadership experience
- Knowledge with the use and interpretation of guidance’s including ICH, USP/NF, EP
- Knowledge and experience of computer software packages (e.g., LIMS, EDMS, etc).
- Strong technical understanding of complex analytical techniques, including HPLC/UPLC, CE, MS, UV, and gel electrophoresis
- Experience with electronic Quality systems (e.g. LIMS, EDMS)
- Experience managing contract laboratories, preferred
- Knowledge of microbiological techniques, preferred
- Knowledge of analytical techniques associated with gene therapy products, preferred
- Travel Requirements 0-10%
EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.