Quality Assurance Manager

Quality Assurance ManagerLocation: Woburn, MAVaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.ResponsibilitiesProvide strategic direction and oversight for the management and development of the Quality Management System to support combination product development and commercialization.Contribute to the ongoing review, strategy development, and operational planning to ensure that all Quality Assurance programs meet applicable regulations and standards.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 Vaxess' 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 ExperienceBachelor's degree in Life Sciences field3 to 5 years in Quality Assurance, in the medical device, biologics andor pharma industries; or 7+ years working in a GXP Environment.Experience in pharmaceutical, biological, and combination product development from preclinical drug development through commercialization preferred.Knowledge with GXP environmentsQuality management of contract service providers (agreements, audits, specification setting, product release)Creative in approach to problem-solvingStrong 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 inspectionsExperience in performing audits of suppliersDemonstration of high-level leadership skills Personal SkillsAttributesQualificationsTimeliness in achieving deliverablesOrganizational skillsSuperior written and verbal communication skillsCollaborative leaderStrong negotiating, influencing and problem-solving skillsAbility to productively interact with contracted service providers and representatives of various government auditing agenciesDetail oriented and hands on in the work environmentTravel: Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CVresume to .

Created: 2025-03-03