Sr. Director, QA (m/f)

Germer International
Baltimore, MD
Mar 14, 2018
Mar 15, 2018
Executive, Director
Full Time
The employer operates within the pharmaceutical industry.Responsible for Quality Operations and QA on the Shop FloorOversight of Change Control, Deviation Management and CAPA Management Quality Systems including responsible for:Manage day to day Quality Operations.Site Deviation Review BoardChange Control Review BoardOverall responsibility for the Investigator Certification Program including Investigation TrainingParticipate as a mentor or QA Partner for Investigations, when requiredTo ensure that siteA cents € (TM) s quality standards, practices, procedures, and documentation are in accordance with regulatory, pharmacopoeia, and corporate global requirements, and industry standards and best practices.To represent QA in internal and external meetings, when required.Support QA Head in the preparation ofA' QA reports including assessment of metrics and KPIsTo complete assigned training's in a timely fashion to ensure that both personal and department training status meets Department and site expectations.To ensure that subordinates are trained and current on applicable global directives, site procedures, and meet minimal job description requirements.A' A' Bachelor's degree or higher in Biology, Chemistry, Pharmacy, (other degrees in combination with relevant experience may be considered)A' 10+ years of relevant work experience in Quality AssuranceA' Thorough understanding of cGMPs, industry and regulatory standards and guidelines, strong ethical foundation and a sound compliance understanding.A' Thorough knowledge and understanding of Deviation/CAPA and Change Control Quality SystemsA' Excellent leadership and interpersonal skillsA' Excellent communication, interpersonal and training skills as well as organizational skills and attention to detailA' Proven ability to establish collaborative working relationships; team oriented and must be able to work independentlyA' Ability to prioritize and manage multiple projects and tasksA' Support the companyA cents € (TM) s equal employment opportunity policy as it applies to all the terms and conditions of employment