Business Systems Analyst role at Manulife bridging business goals and technology solutions across integrated environments. Collaborating with multiple teams to deliver high - quality outcomes.
About the role
- Quality Management System Engineer overseeing quality management for Flow Cytometry software at Dotmatics. Transforming OMIQ SaaS into a validation-ready solution aligned with GxP standards.
Responsibilities
- Oversee and drive quality management framework and processes for Flow Cytometry software
- Transform OMIQ SaaS platform into a fully validation-ready solution
- Architect QMS in alignment with Dotmatics GxP policies and procedures
- Lead validation efforts and serve as the technical face of Quality for biopharma customers
- Design, implement, and maintain a functional QMS for the Flow Cytometry division
- Develop, author, maintain, and train on critical validation documentation
- Define the roadmap for compliance-specific features
- Serve as the technical subject matter expert during the sales cycle
- Partner with Engineering to integrate automated testing and validation checkpoints
- Act as the primary scout for the division on shifting regulatory landscapes
Requirements
- 7+ years in the Biopharma/MedTech space
- 5 years focused on Computer System Validation (CSV) and Quality Management for SaaS
- B.S. or Advanced Degree in Life Sciences (Immunology/Hematology preferred) or Computer Science
- Deep understanding of Flow Cytometry data analysis workflows
- Proven track record of navigating 21 CFR Part 11, GAMP 5, ISO 9001 and/or ISO 13485, and HIPAA/GDPR requirements
- Ability to write a technical risk assessment and lead a strategic product roadmap session
- Exceptional ability to explain complex technical architectures to non-technical Quality Officers
Benefits
- Competitive salary
- Remote work options
- Professional development opportunities
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