Job Description

The Role: (Summary)

We are seeking an experienced Computer Systems Validation expert to lead validation and testing for Spotfire, Statistica, and Redshift. This is a critical role to ensure that the integration functionality functions as designed and as per regulatory expectations.? You will work with a cross-functional team including QC, QA, infrastructure, and other vendors.

Key Responsibilities of the Position:

Author major validation deliverables in alignment with Moderna and regulatory standards. Review and approve CSV deliverables based on identified project deliverables as per defined project phase. To identify and prioritize the system requirements, which can be documented in a software requirements specification. Communicate interdependencies across multiple teams within own area, drive convergence across these teams to ensure smooth functioning of the teams. Manage stakeholder and prepare communications to stakeholders and respond to stakeholder enquiries. Develop and maintain detailed validation and testing documentation, including validation plans, test cases, validation protocols, and reports. Collaborate with Digital, business, and Quality Assurance teams to understand system requirements and ensure appropriate coverage in testing documentation. Ensure all documentation complies with regulatory standards and internal policies. Participate in validation and testing activities, providing support in the execution of test cases and recording results. Conduct thorough reviews of documentation to identify gaps and ensure accuracy and completeness. Assist in the continuous improvement of validation and testing processes and documentation practices. Review project and system life cycle documents against quality requirements with regards to good documentation practice (GDP) under the leadership GDP review of all project documents is in-scope in aspects of good documentation standards - Templates, Completeness, Coherence.

Required Background:

Bachelor's Degree in Life Sciences, Information Technology, Engineering, or a related field Minimum 5 years of relevant job experience in a regulated (GxP) environment 5+ years of job-related experience in Computer System Validation Experience with Regulatory standards and deliverables Hands-on experience with the Spotfire, Statistica, and Redshift Proven track record in CSV with a strong understanding of? CSV/SDLC practices Excellent problem-solving, communication, and documentation skills.
Job Types: Full-time, Permanent

Work Location: In person