With operations in 35+ nations and 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
LES Lab Support Lead - EU/APAC (m/f/d)
In this role you collaborate with LES Lab Support Lead US to formulate and implement a strategy for the global support of LES within the QC labs at Seqirus and CSL Behring, engaging global business partners in QC. You build and maintain a global team at each site for the delivery of application roadmap objectives and BAU activities. Also you create global LES procedures that provide the framework for each site to perform duties associated with lab qualification and compliance activities in accordance with industry best practices, global regulatory standards, and GxP regulations. In this role you are responsible for a team of individuals of the LES Laboratory Support group located at Seqirus and CSL Behring Quality Control sites. You are accountable for the teams who manage lab systems at the Liverpool, Amsterdam, Marburg, Bern and Parkville sites.
You report directly to the Head – Laboratory Execution Systems.
You have the following main responsibilities:
Align with the Manufacturing and Quality global business groups and srovide strategic direction for LES support teams at each site
Interface with Compliance and Digital Quality to ensure principles of Lab management align with CSL standards and with CSL 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
Who you are:
You decisions have global impact due to accountabilities and teams at each site. Your considerations for outcome include multi-site input tempered with overall business needs and goals. You plan strategic direction of LES, and implement solutions for both short and long term success.
The below competencies furthermore contribute to your success:
University Degree in Computer Science, Information Systems, Business Administration, or other related field or equivalent practical experience
5+ 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
This role is available for any of the CSL Behring or Seqirus Manufacturing sites in Europe.
CSL Behring AG Frau Jennifer Meschke Talent Acquisition Switzerland