Sr./Manager, Quality Assurance, PVU (Personalized Vaccine Unit)
The incumbent will provide strong leadership and strategic quality direction both at contract manufacturing organizations (CMOs) and at Moderna's internal manufacturing facility specifically focused on a novel personalized medicine manufacturing platform. This quality professional will directly oversee manufacturing and perform quality release activities for a novel personalized cancer vaccine product directly partnering with key CMO manufacturing and quality leadership. This key individual will act as a subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, cGMP compliance, and in business matters involving pharmaceutical facility and laboratory operations. The incumbent will be tasked with strategic and operational responsibilities pertaining to Moderna's Global Quality System and an integral partner to Moderna's innovative technology platform.
- Provide quality oversight for manufacturing of a novel personalized cancer vaccine product.
- Execute batch release activities (batch = 1 patient) in partnership with CMO to ensure quality product disposition in a timely manner.
- Establish Quality Documentation Systems that define the GMP responsibilities of Moderna's contract manufacturing organizations (CMOs), and issue Certificates of Analysis (COAs).
- Travel initially 50 % to CMO to provide leadership an oversight; travel decreases significantly as focus pivots to start up activities on internal manufacturing capabilities
- Identify and recruit top talent to support novel personalized vaccine platform
- Develop the processes and systems governed by cGXP regulations as well as compliance focused guidance documents and to monitor and control the quality of drug substances, drug products and medical devices at CMOs and Moderna internal manufacturing for a novel personalized medicine manufacturing platform.
- Oversee and monitor Quality Assurance with particular focus on master production and control records in order to ensure that production and control operations are adequately defined and that good manufacturing practices are utilized for the manufacture of drug substances, drug products and devices at CMOs and Moderna internal manufacturing.
- Lead all quality investigations and manage the CAPA (Corrective and Preventative Action) function for CMO activities and Moderna internal manufacturing.
- Initiate and manage compliance standards and procedures throughout the entire organization for CMOs.
- Initiate and manage the Change Control and Document Control systems. Review and coordinate approval of all changes made to manufacturing and control processes including those that are initiated by partner Contract Manufacturing Organizations.
- Establish alert limits for application at time of product release and in the post-approval stability program based on process capability, analytical method variability, and the stability profile of each drug product manufactured by CMOs
- Initiate and maintain the CMO PVU Quality Management System (QMS) for Moderna.
- Conduct and review supplier audits
- Minimum education requirement is a Bachelor's degree, preferably in Sciences or Engineering
- Applied Industry Experience of 8+ Years
- Demonstrated track record of success of in implementing and maintaining quality systems in a biopharma organization
- Travel requirements - 50%
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.