Director Of Quality Assurance

Company: CNA International Executive Search
Location: Dayton
Posted on: February 24, 2021

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