Career | <?phpecho $jobTitle;?> | <?phpecho $companyName;?>

Quality Assurance Manager

Vaxess Technologies

Woburn, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Industry: Vaccine
  • Post Date: 05/23/2023
  • Email:
  • Website:
  • Company Address: 127 Western Avenue, Boston, MA, 02134

About Vaxess Technologies

Needle-free vaccine patch technology.

Job Description

Vaxess Technologies is developing next generation vaccines and therapies based on its proprietary silk
technology. MIMIX™ enables sustained intradermal delivery of vaccines and therapeutics to enhance
efficacy and simplify administration. We are committed to enabling products that are not only more
effective but also more accessible to patients around the world.
We are seeking a talented, collaborative, and highly motivated individual with expertise in document
control and supplier management to join our Quality Assurance team. This is a unique opportunity to be
part of an emerging early phase clinical company bringing innovative technology to the global market.
● Provide strategic direction and oversight for the management and development of the Quality
Management System to support combination product development and commercialization
● Responsible for the ongoing review, strategy development, and operational planning to ensure
that all quality assurance programs meet applicable regulations and standards
● Evolution of quality systems to meet the requirements of the various drug product development
● 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
● Responsible for managing individual and group workload to meet campaign objectives
● Write and revise Standard Operating Procedures
● Responsible for the review and approval of Data
● Manage Vaxess’ 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
Preferred Experience
● Bachelor’s degree in a life sciences field, preferably biological science
● 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
● In-depth knowledge of GLPs, GCPs and GMPs
● 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
● 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
● Timeliness in achieving deliverables
● Excellent 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, a venture-backed clinical-stage life sciences company, is building a team of exceptional people to
rapidly advance products on the MIMIX™ platform. We work closely as a team and thrive in a dynamic,
exciting, and engaging work environment. We aim to recruit, employ, train, compensate and promote
regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation,
disability, age, or veteran status. If you’re interested in joining the Vaxess team, please submit your
CV/resume to