Align with the Manufacturing and Quality global business groups and provide strategic direction for LES support teams at each site
Interface with Compliance and Digital Quality to ensure principles of Lab management align with company standards and with I&T processes
Facilitate cross site communication prior to instrument purchase so that like instruments are procured for similar tasks in the Laboratory domain
Engage with site Managers to ensure LES needs are met in a timely manner and manage escalations across sites, monitoring for trends
Assist with process improvements involving lab instrumentation and technologies
Collaborate with site Managers for efficiency management and continuous process improvement of lab systems, implementing new features, software, or technologies to enhance operational performance
Develop standards for Lab builds in coordination with I&T, including hardware, software, antivirus, backup, and patching
Ensure new lab projects are scoped, budgeted, and scheduled to incorporate LES requirements, conform to regulatory standards, and utilize LES, I&T and pharmaceutical best practices
Create redundancy in lab systems at each site, removing single points of failure
Navigate and assist with PMO and Change Control processes for smooth delivery of LES projects
Interface with instrumentation vendors for information on new Lab equipment and software
Develop BAU budget for each site, incorporating support and routine qualification activities
Work with site and global project teams to create annual budget in support of site and global project initiatives
Advise on LES financial requirements for large capital or special projects and new site build-outs
Plan and prepare for next-generation lab systems through the use of technologies like OS and software virtualization, and be prepared to implement when new technologies are supported by instrument vendors.
Engage vendors and other industry professionals to stay up to date on the latest technology, regulatory trends, and industry best-practices and standards
Manage team and provide guidance and direction for alignment of business needs, as well as conduct performance evaluations for direct reports, manage contracts for outsourced site support teams
Assist Lab Support Analysts in performance feedback of contract staff, train and coach, engaging HR when appropriate. Also explore external education opportunities for teams
Recommend additional training and educational requirements as regulatory and business needs change and mature
University Degree in Computer Science, Information Systems, Business Administration, or other related field or equivalent practical experience
Several years of hands on IT Laboratory support and software validation experience
Experience working in pharmaceutical / biotech industry and with vendor management and budgeting
Knowledge of GAMP 5 framework and SDLC required, as well as GxP, EMA and FDA regulations (including 21 CFR Part 11)
Understanding of Project management framework
Experience in writing SOPs, Validation Documents, Risk Assessments, Verification plans and test scripts
Experience with current Internet technologies / protocols are a plus
Experience in Trackwise, GLIMS, EDMS, SDMS, and E-Learning systems
Experience in Analytical and Pre-Formulation and Formulation system software
Thorough knowledge of Windows desktop and server operating systems, antivirus, Active Directory, storage devices, backup applications, hardware and software virtualization technologies, routers, switches and other solutions
Knowledge and support of standard software packages including Microsoft Office and Adobe productivity tools
Strong written & verbal communication.
Effectively collaborate with peers, cross-functional teams and users across the organization to achieve end-to-end product and process quality
Strong Analytical / problem solving skills.
Ability to be organized and able to multitask
Reputable international company
About Hays With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential.
The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers.
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Yves Fabien Deschamps