Quality Management System Engineer | OMIQ

As the Quality Management System (QMS) lead you will oversee and drive quality management framework and processes that support the delivery of our Flow Cytometry software into regulated biopharma customer environments (typically clinical development and QC labs). In addition to supporting our existing FCS Express clinical and validation-ready software that is already extensively used in regulated labs, this role is especially targeted at transforming our OMIQ SaaS platform into a fully validation-ready solution that meets the requirements of customers wishing to deploy OMIQ into GxP-compliant environments, ensuring our customers can transition from research to clinical trials with absolute confidence in our data integrity and quality standards.

This is a role where the successful candidate will architect our QMS in alignment with Dotmatics GxP policies and procedures as well as industry standard guidance including but not limited to ISO 9001, 13485 (21 CFR part 820), ICH Q10, and PIC/S. Additionally, the person in this role will lead all validation efforts, and serve as the technical face of Quality for biopharma customers using our Flow Cytometry products in alignment with 21 CFR part 11, GAMP 5, 21 CFR part 58, and other relevant regulatory frameworks.

In this role you will get to 

• Quality Management Leadership: Design, implement, and maintain a functional QMS for the Flow Cytometry division that aligns with corporate standards while remaining optimized for SaaS delivery.
• Validation Asset Creation: Deeply engage in the  development, authoring, maintaining and training of critical validation documentation, including User Requirements Specifications (URS), Risk Assessments (FMEA), Configuration Specifications, IQ/OQ/PQ and Validation Summary Reports.
• Product Strategy: Define the roadmap for compliance-specific features, ensuring that audit trails, e-signatures, and data residency requirements evolve alongside clinical regulatory trends (21 CFR Part 11, Annex 11, ALCOA+) and enterprise requirements.
• Customer Advocacy & Sales Support: Serve as the technical subject matter expert during the sales cycle, leading "Quality Deep Dives" with customer Quality Assurance (QA) and IT departments to facilitate successful audits and system adoption.
• Process Integration: Partner with Engineering to integrate automated testing and validation checkpoints into their existing SDLCs, moving toward a model of "Continuous Validation."
• Regulatory Intelligence: Act as the primary scout for the division on shifting regulatory landscapes for clinical software.
• Enterprise Alignment and Partnership: Partner with the Dotmatics Security and Trust team to align QMS, ISMS and GxP programs, continually develop programs and provide input and suggestions into future states.

We are looking for people who have  7+ years in the Biopharma/MedTech space, with at least 5 years specifically focused on Computer System Validation (CSV) and Quality Management for SaaS, and hold a B.S. or Advanced Degree in Life Sciences (Immunology/Hematology preferred) or Computer Science.
The key skills we are looking for 

• Computer System Validation (CSV) and Quality Management for SaaS.
• Technical Domain Knowledge: Deep understanding of Flow Cytometry data analysis workflows and the unique challenges of high-dimensional biological data.
• Regulatory Mastery: Proven track record of navigating 21 CFR Part 11, GAMP 5, ISO 9001 and/or ISO 13485, and HIPAA/GDPR requirements.
• A Hybrid Skillset: Ability to write a technical risk assessment in the morning and lead a strategic product roadmap session in the afternoon.
• Communication: Exceptional ability to explain complex technical architectures to non-technical Quality Officers and vice-versa. Able to teach and train staff on Validation, GxPs, and processes.
• Risk Management: Ability to “right-size” Quality systems and validation efforts based on the overall risk of the product as related to patient safety, product quality, data integrity, confidentiality, and availability.