Manager, Quality Control (LIMS)
300 Rouse Boulevard Philadelphia, PA 19112 US
Manager, Quality Control (QC), who will be responsible for oversight of the QC Laboratory Information Management System (LIMS). S/he will represent QC in the development, configuration, validation, implementation and maintenance of the LIMS as it relates to QC functionality including analytical and microbiology testing, environmental monitoring, raw materials, stability and sample management to support compliance with regulatory requirements and commitments for clinical and commercial products.
S/he should have a good understanding of, and experience with LIMS within a cGMP-regulated environment. The position will report to the Senior Director, Quality Control.
- Collaborate with stakeholders to develop the requirements and the long-term vision for LIMS.
- Drive development and implementation of the LIMS by partnering with IT and external vendors.
- Develop and regularly update key project information such as status, timelines, scope statements, budgets, resources, risks, issues, decisions, and action items.
- Manage enhancements, incident investigation, and changes for a multi-site, global LIMS
- Draft program related support documents including operational SOPs, Work Instructions, System Impact assessments, change controls.
- Track and resolve LIMS support program issues and identify potential enhancements to the system.
- Independently plan, manage and execute assignments, contribute to project planning meetings.
- Support product stability programs including generation of stability protocols in LIMS, and support as needed accessing final reporting or trending of stability data
- All duties are performed with minimal supervision and oversight
Education and Qualifications:
- Bachelor’ s degree in a relevant discipline (biological sciences, computer science or equivalent)
- Minimum (8) years of experience in a cGMP laboratory including at least 3 years as a LIMS administrator. Experience with configuring and implementing a LIMS
- Experience with translating business documents (batch records, test methods, stability protocols) into technical requirements and configuring in a LIMS solution.
- Experience with cell and/or gene therapy products is a plus.
- Experience implementing and supporting LIMS such as Labware, MODA, LabVantage.
- Experience with MS SQL Server or Oracle database is a plus.
- Ability to manage external partners with respect to quality control activities
- Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
- Problem solver who not only identifies issues but leads efforts to resolve them
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