What do we need
We are seeking a high-ownership, detail-oriented operator to help drive cross-functional initiatives spanning finance, systems, compliance, and business transformation. This role is ideal for someone with 3 to 5 years of experience in audit, IT risk, internal controls, or risk advisory who wants to pivot into a broader operations role with meaningful exposure to execution, systems implementation, and enterprise change.

You will work across business operations, finance, legal, commercial systems, and shared services to help lead strategic initiatives from planning through execution. The role requires someone who is comfortable structuring ambiguous problems, managing multiple stakeholders, tracking workstreams rigorously, and driving programs forward in a practical way. This role will also work on our Siemens integration projects. 

The right candidate is someone who has developed strong discipline, organization, and risk awareness in their prior role, you may come from a Big4 or similar background, but now wants to apply those skills in a more dynamic operating environment with broader business and operational exposure.

In this role you will get to 

•     Manage cross-functional programs that touch finance, legal, tax, compliance, and revenue operations.
•     Build and maintaining clear project plans and stakeholder communications across multiple concurrent initiatives.
•     Drive execution across complex change programs, including process redesign, systems implementation, data migrations, and operating model transitions.
•     Partner with internal stakeholders to improve workflows, increase automation, and strengthen operational maturity.
•     Support budget tracking, spend visibility, and reporting for strategic investment areas
•     Help coordinate large-scale business process and systems changes, including requirements gathering, issue tracking, testing coordination, training support, and go-live readiness across our internal projects and our Siemens integration projects 
•     Identifying operational risks, process gaps, handoff failures, and control considerations, then helping design practical solutions.
•     Acting as a connective tissue role across teams by ensuring decisions are documented, owners are aligned, timelines are maintained, and open items are resolved.

We are looking for people who have 5 years of experience in audit, IT risk, internal audit, risk advisory, internal controls, or a related environment who wants to pivot into a broader operations role.

The key skills we are looking for 

•     Experience working on cross-functional projects involving systems, process change, governance, risk, or operational execution.
•     Strong project management instincts, including the ability to organize complex workstreams and keep multiple stakeholders aligned.
•     Comfort operating in ambiguity and helping bring structure to initiatives that are still being defined.
•     Strong written and verbal communication skills, especially the ability to synthesize issues clearly and drive follow-up.
•     Experience working with enterprise systems, process documentation, workflow design, or implementation support is preferred.
•     Familiarity with finance, legal, tax, compliance, or revenue operations processes is a plus.
•    Some exposure to CRMs or other business systems is a plus.

What do we need 

As the Quality Management System (QMS) owner 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.

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.