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Director, Quality Assurance - GxP

Company: SciPro
Location: New York
Posted on: January 17, 2020

Job Description:

A Global pharmaceutical company that is an industry leader with a focus in Ultra-rare metabolic disease therapy is looking for a new Director of Quality Assurance - GxP. The focus of this role is to create process, policies, and procedures in an unstructured environment, ensure compliance with international regulations, implementation of effective quality management systems, and overseeing global audits in various capacities. This is a great time to get into this role, as the company is operating multiple exciting trials centred on new cell & gene therapies. Responsbilities: Managing GPV/ GLP/ GCP / GMP audits of vendors, processes and systems. Overseeing and documenting vendor, process and system risk assessments including ensuring CAPA completion Maintaining inspection readiness; Pharmacovigilance -System Master File (PSMF) revisions, Strategic and Tactical plans, Standard Operating Procedure (SOP) review and revision. Experience/Qualifications: Experience in GPV/ GLP/ GCP / GMP related to QA in clinical trials. Strong clinical auditing experience (PV, GCP, GLP quality). Experience performing audit response with CAPA implementation processes. Experience adverse event reporting in both developmental and commercial aspects. Experience attending PV/clinical operational meetings to support PV QA program development timelines and ability to meet key deliverables. Knowledge and application of global regulatory standard PV related 21CFR & EU directives/legislationThis role offers the chance to join a company at an exciting and integral time and be a vital part of this team and the exciting therapy trials that are underway there.

Keywords: SciPro, New York , Director, Quality Assurance - GxP, Executive , New York, New York

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