Gxp & Research Applications In California
This is a new opportunity for a director, gxp & research applications full-time position in california. Overview: reporting to the vp of information technology, this position will be responsible for defining and maintaining global gxp and r&d application services. The successful candidate will have extensive experience with pharmaceutical and biotech it systems, vendor management, cross-functional team management, cfr part 11 and gamp 5 regulations, systems validation, and change control. This position will provide leadership to the application services team and the company. It will consult with the business to achieve successful gxp and r&d system development and completion of the it department’s objectives, projects and priorities. He or she will provide work direction, development coaching and performance feedback to application services staff while establishing and maintaining positive relationships with relevant business partners. Responsibilities: -provide production and development support for existing and future multi-tier gxp and research applications. -execute agreed upon service levels (i.E. Project schedules, system availability, & service quality). -review systems requirements and prepare recommendations anticipating future application needs. -direct the analysis, design, development and installation of it supported applications in accordance with established sops. -direct the it process development team to establish and maintain it sops, wis and related documents. -partner with qa to manage systems validation, periodic reviews and vendor assessments. -prepare operational forecasts and requirements, including monthly reports and budget analyses. -provide regular performance feedback to employees including written performance reviews. Lead individual projects as assigned using software development life cycle (sdlc) methodologies. Qualifications: -bs degree in computer science, business or equivalent experience. -ten to fifteen years of experience supporting gxp it systems with 3 to 5 years’ experience in the following: -it biotech project management experience in a multinational environment; -it management experience in a biotech/pharmaceutical environment managing systems supporting drug safety, pharmacovigilance, regulatory compliance, quality management and compliance, medical information or clinical trials software; and, -it working knowledge in a biotech research and lab environment, familiar with lab systems implementation and system requirements. -working knowledge of cfr part 11 requirements and direct experience with systems implementation in a validated environment. -must possess an understanding of business processes related to pharmaceutical corporate activities. Contact us here on zintro for more details.
Marie |Regulatory compliance/Quality System/ASQ
Hello: I have 14 years experience working in the industry. I have been a certified auditor since 2...10.5 Hours Later
Frank |Zintro Expert
Dear Sir/Madam, I have the required experience and ***** excel at this position. Experience...10.7 Hours Later