GMP Quality Assurance PVU Senior Manager

Moderna

(Cambridge, Massachusetts)

Full Time Travel Required

Job Posting Details

About Moderna

Moderna is a clinical stage pioneer of messenger RNA Therapeutics™, an entirely new in vivo drug technology that produces human proteins, antibodies and entirely novel protein constructs inside patient cells, which are in turn secreted or active intracellularly.

Summary

The Sr. Manager/Associate Director GMP Quality will provide strong leadership and strategic direction to Moderna Therapeutics Quality Management System, consisting of the Quality Assurance, and Compliance and is responsible for ensuring the overall quality of our investigational drug Processes and drug candidates at contract manufacturing organizations (CMOs) specifically focused on a novel personalized medicine manufacturing platform. 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.

Responsibilities

* Line leadership and cross functional leadership of quality focused teams across Moderna’s broad ecosystem of functions
* 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 for a novel personalized medicine manufacturing platform
* Establish Quality Documentation Systems that define the GMP responsibilities of Moderna’s contract manufacturing organizations (CMOs), and issue Certificates of Analysis (COAs)
* Oversee and monitor Quality Assurance standards throughout the entire organization 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
* Define and oversee standards for the testing of components, drug substance, drug product, in-process materials internally and at the CMOs. Lead all quality investigations and manage the CAPA (Corrective and Preventative Action) function for CMO activities.
* 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 Quality Management System (QMS) for Moderna
* Conduct and review supplier audits

Line leadership and cross functional leadership of quality focused teams across Moderna’s broad ecosystem of functions
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 for a novel personalized medicine manufacturing platform
Establish Quality Documentation Systems that define the GMP responsibilities of Moderna’s contract manufacturing organizations (CMOs), and issue Certificates of Analysis (COAs)
Oversee and monitor Quality Assurance standards throughout the entire organization 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
Define and oversee standards for the testing of components, drug substance, drug product, in-process materials internally and at the CMOs. Lead all quality investigations and manage the CAPA (Corrective and Preventative Action) function for CMO activities.
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 Quality Management System (QMS) for Moderna
Conduct and review supplier audits

Ideal Candidate

Minimum Qualifications

Minimum education requirement is a Bachelor’s degree
Applied Industry Experience of 10+ Years
Demonstrated track record of success of in implementing and maintaining quality systems in a biopharma organization
Travel requirements – 25%

Preferred Qualifications