Manager, Quality (Gaithersburg, MD)(Req# 14-101) Altimmune, Inc.
THIS JOB HAS EXPIRED 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
THIS JOB HAS EXPIRED
Altimmune (formerly known as Vaxin) is focused on products that engage the immune system to prevent and treat disease. We strategically employ our two distinct and complementary immune platform technologies to create innovative products for important diseases.
Beta Test / Clinical Trials Investors: Redmont Venture Partners All Jobs: at Altimmune, Inc.
|Headquarters:||19 Firstfield Road|
Gaithersburg, MD 20878
|Company Profile:||Altimmune is a clinical stage immunotherapeutic biotechnology company located in Montgomery County, MD with additional operating sites in London, UK and Strasbourg, France. By leveraging the complementary attributes of its two innovative vaccine delivery platforms, RespirVec- and Densigen-, Altimmune is able to rationally design and rapidly develop immunotherapeutic products tailored to address the a wide range of disease indications including acute respiratory infections, chronic viral infections and cancer with fundamental advantages over competing products.|
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