We are hiring a Quality Assurance Specialist (Pharma/CRO)

At Cohortias, we are looking for a detailed, proactive, and collaborative Quality Assurance Specialist (QAS) to support the operational execution and continuous improvement of our Quality Management System (QMS).

This is a Specialist I role designed for a clinical quality professional who thrives on day-to-day quality oversight, document control, audit execution, and CAPA management across clinical research operations. Working in a lean CRO environment, you will play a key role in fostering a transparent, compliant, and proactive quality culture.

? Location: Mexico City (Hybrid Model)

About the Role & Scope:

As our QAS, you will cover the complete operational cycle of clinical quality assurance. You will oversee controlled-document maintenance, track CAPAs and deviations, respond to GCP queries from operational teams, and participate directly in internal, site, and vendor audits.

Additionally, you will support audit readiness for health authority inspections (COFEPRIS, FDA, EMA) and sponsor audits, ensuring our clinical trial activities strictly adhere to integral regulatory standards.

Key Responsibilities:

- QMS & Document Control: Maintain and update SOPs, Work Instructions, and controlled forms, tracking review cycles and ensuring full document availability across teams.
- CAPA & Deviation Tracking: Monitor Corrective and Preventive Actions (CAPA) and deviation workflows, tracking closure timeliness and analyzing root-cause effectiveness.
- Audit Execution & Readiness: Plan, prepare, and execute assigned audits within the annual audit plan. Support sponsor audits and regulatory inspection readiness (COFEPRIS,



FDA, EMA).
- Operational GCP Advisory: Serve as a point of contact for Clinical Operations, Data Management, and Regulatory teams, providing practical GCP interpretation and quality guidance.
- Risk-Based Quality Management (RBQM): Support quality risk assessments (ICH Q9), track quality metrics, and analyze trends in audit findings to identify systemic risks.
- Compliance Oversight: Assess computerized systems and data integrity standards (21 CFR Part 11, ALCOA++) and participate in technology provider qualification.

What We Are Looking For:

- Industry Experience: Minimum of 2 years of experience in Clinical Quality Assurance, Clinical Operations, or related roles strictly within a Pharmaceutical, Biotechnology, or CRO company.
- GCP & Regulatory Mastery: Solid working knowledge of ICH-GCP guidelines (E6 R2/R3, E8 R1), Quality Risk Management (ICH Q9), and health authority expectations (COFEPRIS, FDA, EMA).
- QMS Core Competencies: Practical experience with controlled document management, CAPA tracking, deviation investigations, and audit participation.
- Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific field (Master’s degree or RQAP-GCP certification is a plus).
- Technical Aptitude: Familiarity with data integrity principles (ALCOA++), 21 CFR Part 11, and tracking quality KPIs via spreadsheets or QMS tools.
- Languages: Advanced English (fluent written and spoken) for cross-functional and global communication.

Interested in this role or know someone who is a great fit?

Apply today and become part of the team that is redefining clinical research in the region.

📌 Quality Assurance Specialist (Pharma/CRO) (Ciudad de México)
🏢 Cohortias
📍 Ciudad de México