Senior Manager, Digital Labs - SDLC Coordinator

Role Overview:

Join us and be part of our dedicated team that provides support for our Laboratories to improve efficiency, reporting and compliance while improving LIMS Platform stability and useability. This opportunity will also involve working on our Laboratory Transformation program, which is a multi-year, phased approach to streamline and standardize our QC labs to prepare each site to a level playing field of maturity for full digitalization.

What will you do in this role:

• Manage all the System Development Lifecycle (SDLC) activities and records for the Global LIMS Labware platform.
• Manage multiple validation personnel including internal resources and external contractors.
• Create validation work estimates for projects.
• Contribute to improving the validation processes to improve quality and delivery efficiency.
• Ensure compliance to all procedures, especially quality procedures.
• Create and/or support the execution of Development Testing (DT) and User Acceptance Testing (UAT) Test Scripts
• Create Test Summary Documents
• Identify and Report test/system Defects.
• Create and Update validation deliverables such as Requirements, Risk Assessments, Trace Matrices and Test Plans.
• Develop and maintain good Labware Product knowledge
• Willingness and ability to collaborate/communicate with the Global LIMS Team and Quality Stakeholders.

What Should you have:

• Bachelors degree in a Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics field.
• Experience managing a team with ability to motivate.
• 3+ years of experience in software testing, preferably Labware LIMS.
• Familiarity with testing tools and methods e.g. JIRA, Microsoft Teams, etc.
• Strong analytic, critical thinking and problem-solving skills
• Attention to detail.
• Strong Organizational, writing and documentation skills
• Experience with Agile Methodologies
• Self-motivated
• Experience in Pharma Industry preferred with knowledge of cGMP and Laboratory processes
• Good Communication Skills including fluency in English