Manager, Quality (Gaithersburg, MD)(Req# 14-101) Vaxin
Summary of Position
This position within the Quality program provides day-to-day management of functions to support product development, manufacturing, testing, and release of clinical trial and nonclinical materials in accordance with regulatory requirements and quality standards. This position is required to work with both internal and external parties to provide direction on compliant operational practices. This position will provide review of production and testing raw data/reports, work with various groups/vendors to oversee investigations, design/utilize quality systems, and compile/present quality metrics. Assist in preparing PowerPoint presentations on progress in company Quality Systems and Quality strategy. May occasionally travel nationally/internationally and represent the company during audits and technical visits.
Provide quality oversight to vendors and internal laboratories. Monitor adherence to company policies and procedures.
Conduct audits and review records to support product release, non-clinical and clinical data reporting.
Drive product quality improvements, evaluate product batches, coordinate investigations/CAPA, and compile metric evaluations.
Manage contracted QC activities (e.g., testing activity oversight, report review, and sample submissions).
Manage internal Quality Systems (e.g., vendor control, change control, and document control).
Train quality employees, and author/revise corporate quality SOPs.
Collaborate to formally present training sessions, quality concerns/updates internally and to clients.
Assist in preparing and formally presenting Quality strategy internally and externally.
Other duties as assigned.
Job Requirements (Essential knowledge, skills and attributes)
Bachelor?s degree or greater in science, pharmacy or engineering required, Master?s degree preferred.
Seven to twelve years of compliance related experience with regulated activities.
Compliance experience at a biotechnology/pharmaceutical organization.
Working knowledge of GMP regulations necessary.
Working knowledge of GLP and GCP regulations preferred.
Experience with vendor auditing/management, and investigations preferred.
Skills in regulatory compliance inspection and project management.
Strong interpersonal skills (e.g., listening, writing, facilitation, presentation).
Ability to work in a collaborative environment.
Vaxin is an equal opportunity employer that values diversity
||19 Firstfield Road |
Gaithersburg, MD 20878
Vaxin Inc. is an emerging vaccine company using non-invasive means to elicit immune responses. Our lead programs are vaccines to prevent disease caused by Influenza (phase I), Anthrax, and Avian Influenza.
Beta Test / Clinical Trials Investors: Redmont Venture Partners All Jobs: at Vaxin
|Headquarters:||19 Firstfield Road|
Gaithersburg, MD 20878
|Company Profile:||The Company's proprietary technology consists of non-replicating adenovirus and bacterial vectors that can deliver antigens non-invasively (to the nasal passages or to the skin) to elicit a protective immune response. The nasal mucosa and the skin contain cells that participate in the body's protection mechanism against disease causing pathogens. Vaxin's technology harnesses this pre-existing feature of our immune system.|
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