Job Description

Quality Assurance Manager

Location: Woburn, MA

Vaxess 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.

Responsibilities

• Provide 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 Experience

• Bachelor’s degree in Life Sciences field
• 3 to 5 years in Quality Assurance, in the medical device, biologics and/or 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 environments
• Quality management of contract service providers (agreements, audits, specification setting, product release)
• Creative in approach to problem-solving
• 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
• Demonstration of high-level leadership skills

Personal Skills/Attributes/Qualifications

• Timeliness in achieving deliverables
• Organizational skills
• Superior written and verbal communication skills
• Collaborative leader
• Strong negotiating, influencing and problem-solving skills
• Ability to productively interact with contracted service providers and representatives of various government auditing agencies
• Detail oriented and hands on in the work environment
• Travel: <25%

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 CV/resume to [email protected] .

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