Quality Assurance Manager

Our pharmaceutical client here in the Woburn, MA area is growing and looking to hire a Manager Sr. Manager, QA to their team! This role will provide strategic direction and oversight for the management and development of the QMS to support their combination product development and commercialization! In addition, this role will contribute to the ongoing review, strategy development, and operational planning to ensure that all Quality Assurance programs. Other responsibilities include but are not limited to:Evolve Quality Systems parameters to meet requirements of various drug and device development stages.Partner with GXP Operations to assist in oversight of contract service providers.Assist Regulatory Affairs in the preparation and review of product development data for regulatory submissions.Implement pre-approval inspection readiness program.Manage individual and group workload to meet Company objectives.Write, Review, Edit and Approve Standard Operating Procedures.Write, Review, Edit and Approve Analytical Test Methods.Manage the Document Control, Training, Equipment and Metrology programs.Maintain an ongoing understanding of and adaptation to the pharmaceutical, biologics, and medical device industries including staying abreast of quality issues within industry and government.Preferred Requirements:Bachelor's degree in Life Sciences field AND 3 to 5 years in Quality Assurance, in the medical device, biologics andor pharma industries; OR 7+ years working in a GXP Environment (manufacturing or analytical development preferred).Experience in pharmaceutical, biological, and combination product development from preclinical drug development through commercialization preferred.Knowledge with GXP environments. Quality management of contract service providers (agreements, audits, specification setting, product release).Strong knowledge of product development technical strategy as well as systems strategy; must also be able to tie technical and systems strategies into the overall business strategy.Experience in managing regulatory inspections.Experience in performing audits of suppliers (preferred).Excellent written and verbal communication skills.Excellent skills in managing technical and human resources.Experience in supporting the development of data for regulatory applications and submissions.Experience in leading pre-approval inspection readiness activities.

Created: 2025-03-03