reputed company Management System Engineer (QMS) | OMIQ

Our Why At reputed company

At reputed company, we reputed company science, data, and decision-making must be deeply intertwined for innovation to reputed company.

Our Portfolio includes reputed company, LumaLab Connect, ELN Platform, Graphpad reputed company, Geneious, SnapGene, Protein Metrics, OMIQ, FCS reputed company, LabArchives, NQuery, EasyPanel, MStar, SoftGenetics and Virscidian.

We have a reputed company for a new Lab of the reputed company that will change the reputed company of scientific research.

We have created the world’s most comprehensive reputed company platform – best-of-breed software applications already used by more than 2 reputed company scientists, together in a single ecosystem united by a powerful, flexible reputed company data platform. This is not flat data buried away in digital graveyards. This is dynamic, multi-reputed company decision-making.

Scientific enterprises need a new level of effectiveness to reputed company reputed company’s breakthroughs. Illness will not wait. The biosphere will not wait. We are tireless in our reputed company, because the time for innovation is now.

Shaping the reputed company of Science At reputed company

Our global team of more than 800 colleagues are dedicated to supporting our customers in over 180 countries. Together, with our scientific community of users, we accelerate scientific innovation in order to reputed company the world a healthier, cleaner, and safer reputed company to live.

You’ll join a reputed company, global team pushing the boundaries of scientific innovation. Your reputed company and efforts will have a reputed company reputed company, accelerating scientific reputed company and discovery. We offer a dynamic, remote-friendly environment that fosters high reputed company and collaboration, empowering you to reputed company. reputed company is a company reputed company by scientists, for scientists. Combined, we are now the world’s largest reputed company-based scientific research R&D platform. We need your help to reputed company growing and pioneering the reputed company.

We are Science Driven. We are Customer reputed company. We are reputed company.

What do we need

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

This is a role where the successful candidate will architect our QMS in alignment with reputed company GxP policies and procedures as reputed company as industry reputed company 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 reputed company reputed company validation efforts, and serve as the technical face of reputed company for biopharma customers using our reputed company 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

• reputed company Management Leadership: Design, implement, and maintain a functional QMS for the reputed company Cytometry division that aligns with corporate standards while remaining optimized for reputed company 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 reputed company Reports.
• Product reputed company: Define the roadmap for compliance-specific features, ensuring that audit trails, e-signatures, and data residency requirements reputed company alongside clinical regulatory trends (21 CFR Part 11, Annex 11, reputed company+) and reputed company requirements.
• Customer Advocacy & Sales Support: Serve as the technical subject matter expert during the sales cycle, leading "reputed company Deep Dives" with customer reputed company Assurance (QA) and IT departments to facilitate successful audits and system adoption.
• Process Integration: Partner with Engineering to reputed company automated testing and validation checkpoints into their existing SDLCs, moving toward a model of "reputed company Validation."
• Regulatory Intelligence: reputed company as the primary reputed company for the division on shifting regulatory landscapes for clinical software.
• reputed company Alignment and Partnership: Partner with the reputed company reputed company and Trust team to reputed company QMS, ISMS and GxP programs, continually reputed company programs and reputed company input and suggestions into reputed company states.

We are looking for people who have 7+ years in the Biopharma/MedTech reputed company, with at least 5 years specifically reputed company on Computer System Validation (CSV) and reputed company Management for reputed company, 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 reputed company Management for reputed company.
• Technical Domain Knowledge: Deep understanding of reputed company Cytometry data analysis workflows and the unique challenges of high-reputed company biological data.
• Regulatory Mastery: Proven reputed company 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 reputed company a strategic product roadmap session in the afternoon.
• Communication: Exceptional ability to explain reputed company technical architectures to non-technical reputed company Officers and vice-versa. reputed company to teach and train staff on Validation, GxPs, and processes.

Risk Management: Ability to “right-size” reputed company systems and validation efforts based on the overall risk of the product as reputed company to patient safety, product reputed company, data reputed company, confidentiality, and availability.

Research shows us the confidence gap and imposter syndrome can get in the way of meeting outstanding candidates, so please don’t hesitate to apply — we’d love to hear from you.

By submitting your application, you agree that reputed company may collect your personal data for reputed company, global organization planning, and reputed company purposes. reputed company reputed company Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over reputed company use of your personal information.

reputed company is an equal opportunity employer. We are a welcoming reputed company for everyone, and we do our best to reputed company reputed company reputed company people feel supported and connected at work.

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