Director Of Quality Assurance
Company: CNA International Executive Search
Location: Dayton
Posted on: February 24, 2021
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Job Description:
BEFORE READING THE JOB YOU MUST LIVE IN THE STATE OF NEW JERSEY!
Please do not apply if you don't.
Our Client is expanding rapidly and is now looking for their first
Quality Assurance employee who will be the QA compliance strategist
for the company as well as the implementation expert. Working
within Clinical Operations reporting to General Counsel in the
Legal Department.
Essential Responsibilities:---GxP compliance strategy,
implementation and surveillance---Develop and maintain Quality
programs and appropriate quality systems (MasterControl) to support
clinical phases 2 and 3 as well as commercial preparation---Gap and
risk assessment assess and analyze gaps, plans and executes
risk-based strategy for GCP and GMP---Advise on technical and
quality agreements, global and domestic development strategies for
clinical products---Reviews study protocols, and regulatory
submissions documents---Oversight and audit for multiple domestic
and international CROs, CMOs---Oversight of raw materials
suppliers, service providers---Reviews batch documentation
---Determines disposition of all clinical products
Knowledge & Experience:---Proven Quality Assurance Management
experience domestic and international in Biotech, Biosciences or
Pharma companies---At least 5 years in a small company
environment---MasterControl or a similar DMS (Document Management
System)---Experienced in both GCP and GMP QA ---Solid experience in
working with external partners (CROs, CMOs and
consultants)---Ability to work collaboratively with all
functions---Excellent communication skills are required---Ability
to be a team player ---Demonstrated results at both a strategic and
hands on level in managing pre and post approval QA relationships
---Ability to be the only QA person in the organization
Keywords: CNA International Executive Search, Trenton , Director Of Quality Assurance, Executive , Dayton, New Jersey
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