Quality Systems Specialist - Legal; Risk & Compliance

Signant Health; Ciudad de México; Presencial; MXN 350 000 - 700 000; Tempo integral

Resumo da oferta

Signant Health in Mexico City is seeking a Quality Systems Specialist to administer QMS, control documents, coordinate training, and generate metrics. The ideal candidate will help maintain and optimize the QMS platform and related systems, implement and manage document control processes, and contribute to the generation of metrics.

The role requires technical expertise in quality management systems, organizational skills, creativity, and critical thinking.

Qualificações

• 3+ years of quality experience in Life Sciences or related field.
• Excellent verbal and written communication, including technical writing.
• Excellent organizational and time management skills.
• Critical thinking, troubleshooting, and problem-solving.
• Deep understanding of quality management principles.

Responsabilidades

• Monitor QMS performance, implement improvements, and troubleshoot issues.
• Manage user accounts, roles, permissions, and access controls within the QMS.
• Provide support to QMS users across departments.
• Generate and analyze quality metrics and reports from the QMS.
• Manage document control processes and workflows.
• Manage training materials and documentation.
• Coordinate with management to identify training priorities.
• Ensure training is appropriately assigned.
• Other project work and responsibilities as required.

Conhecimentos

Quality systems

GxP know-how

Regulatory knowledge

Documentation

Training coordination

Ferramentas

Dot Compliance

MasterControl

TrackWise

Veeva

LMS

Descrição da oferta de emprego

At Signant Health, we help bring life-changing treatments to patients faster. We are a global evidence generation company that supports clinical trials with smart technology, scientific expertise, and hands-on operational support — so better data leads to better decisions in healthcare. We embrace AI and advanced technologies to enhance every aspect of what we do, from data analysis to operational efficiency.

Our teams work at the intersection of science, technology, and patient experience, delivering digital solutions powered by AI innovation that make clinical trials more efficient, more accurate, and more accessible around the world. Trusted by leading pharmaceutical companies and CROs, our platforms and services support studies across more than 90 countries and have contributed to hundreds of new drug approvals.

If you are motivated by meaningful work, global impact, and innovation in clinical research and digital health — including the opportunity to work with cutting-edge AI technologies — you will find purpose and opportunity at Signant Health.

About The Role

This position combines Quality Management System (QMS) administration, document control, training coordination, and metrics responsibilities. The ideal candidate will help maintain and optimize the QMS platform and related systems, implement and manage document control processes, coordinate training for staff, and contribute to the generation of metrics. This role requires technical expertise in quality management systems, organizational skills, creativity, and critical thinking.

Key Accountabilities

• Monitor QMS performance, implement improvements, and troubleshoot issues
• Manage user accounts, roles, permissions, and access controls within the QMS
• Provide support to QMS users across departments
• Generate and analyze quality metrics and reports from the QMS
• Manage document control processes and workflows
• Manage training materials and documentation
• Coordinate with management to identify training priorities
• Ensure training is appropriately assigned
• Other project work and responsibilities as required.

Knowledge, Skills & Attributes

• 3+ years of Quality experience in a Life Sciences or related field
• Excellent verbal and written communication skills, including technical writing capability
• Excellent organizational and time management skills
• Critical thinking skills, including technical troubleshooting and problem-solving
• Deep understanding of quality management principles
• Risk assessment and mitigation abilities
• Strong presentation and facilitation skills, including ability to explain technical and quality concepts to various audiences
• Adaptability and willingness to learn new technologies and regulations
• Self-motivated with the ability to work independently
• Experience with validation of computer systems in regulated environments
• Experience with electronic QMS solutions (Dot Compliance, MasterControl, TrackWise, Veeva, etc.)
• Knowledge of regulatory requirements for documentation (ISO, FDA, cGMP, etc.)
• Experience with Learning Management Systems (LMS)

Why Signant Health?

At Signant Health, your work has real impact. Everything we build, support, and deliver helps advance clinical research and bring new treatments to patients faster — improving lives around the world. Our teams combine science, technology, and operational expertise to solve complex clinical trial challenges, and every role contributes to that mission.

We offer a collaborative, global environment where you can grow your career while working alongside experts across clinical, technology, data, and operations, with opportunities to learn, take ownership, and drive meaningful innovation — not just maintain the status quo.

If you are looking for purpose-driven work, smart colleagues, and the opportunity to help shape the future of clinical research and digital health, Signant Health is the place to do it.

At Signant Health, accepting difference isn't enough — we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients, and our community. We are proud to be an equal opportunity workplace and an affirmative action employer, committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status. Prior to their start date, all new hires are required to be verified through a thorough background check and identity verification to confirm eligibility for employment.

Unsolicited resumes submitted by agencies or third-party recruiters directly to hiring managers or any Signant Health employee will not be considered and will not obligate Signant Health to any fees or terms associated with the submission.