New job JOB OPENING: Senior Director, Quality Engineering

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: JOB OPENING: Senior Director, Quality Engineering Andy Ellis posted a job: JOB OPENING: Senior Director, Quality Engineering "JOB DESCRIPTION: The primary purpose of this position is to ensure manufacturing is meeting quality requirements set forth by cGMPS, by FDA and other major international regulatory agencies (E.g. EMA, TGA, ANVISA), the company’s quality systems and customer requirements. This role will set quality and regulatory strategy for the organization to ensure the business continuity of the company, supporting the maintenance of its licence to operate in the high end pharmaceutical custom manufacturing space. This position is responsible for setting up a data monitoring and trending system to analyse the performance of manufacturing operations as expected by cGMP’s. The position will analyze trends and deviations to develop continuous improvement plans resulting in safer medicine, higher first time right (FTR) and consequently higher company profitability and reputation in the industry. The implementation and continuous adjustments of FDA mandated Quality by Design (QbD) concepts and risk based process controls are key elements of the position. This position manages the Quality Assurance, Quality Continuous Improvement, Technical Training and Quality Process Engineering departments. Educational and Experience Requirements: -BS/BA in Chemical, Biological or related Science with 9 years managerial experience in the pharmaceutical industry OR Masters with 7 years Managerial experience in the pharmaceutical industry OR PHD with 5 years Managerial experience in the pharmaceutical industry. -At least 5 years of experience working directly with regulatory agencies. At least 5 years of pharmaceutical experience in QA, QC or regulatory affairs. --Salary: A competitive compensation package. --email resumes to andyellis@pellis.com"

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