We are hiring a Quality Assurance Specialist – IT Compliance & CSV (Pharma/CRO)

At Cohortias , we are looking for a specialized QA professional to oversee our technology ecosystem. This is not a traditional clinical or manufacturing QA role , nor a general IT position—we are seeking an expert in GxP Computerized System Validation (CSV), data integrity, and technology governance within the pharmaceutical or CRO industry.

Location: Mexico City (Hybrid Model)

About the Role:

As a Quality Assurance Specialist (GxP Systems & CSV) , you will serve as the independent Quality Unit point of contact for Computerized System Validation (CSV/CSA), Data Integrity, and IT vendor governance. You will ensure that our eClinical platforms, cloud infrastructure, and software providers comply with international regulations (FDA, EMA) and GxP standards throughout their lifecycle.

Key Responsibilities:

- Provide independent QA oversight for the validation lifecycle of GxP computerized systems (CSV/CSA) under GAMP 5 guidelines.
- Monitor and evaluate compliance with electronic records and signatures regulations (21 CFR Part 11 and EU Annex 11 ).
- Conduct risk-based quality audits and evaluations covering information security (ISO 27001), data privacy (GDPR), and business continuity (ISO 22301) for IT and eClinical technology vendors.




- Oversee IT/GxP vendor qualification, Quality Agreements, SLAs, and change control processes.
- Review and approve root cause analyses (RCA), deviations, and CAPA plans for system and technology-related incidents.
- Drive Quality Risk Management (ICH Q9) and contribute to continuous QMS improvements and internal ALCOA+ training.

What We Are Looking For:

- Industry Experience: 5-7 years of Quality Assurance experience strictly within the pharmaceutical, biotech, medical device, or CRO industry .
- Specialization: At least 2 years of hands-on experience in GxP Computerized System Validation (CSV), system compliance, and technology vendor oversight.
- Education: Bachelor's degree in Life Sciences, Pharmacy, Computer Science, Software Engineering, or related fields.
- Technical Expertise:
- In-depth mastery of GAMP 5 , 21 CFR Part 11 , EU Annex 11 , and ALCOA+ / ALCOA++ data integrity frameworks.
- Solid understanding of ICH guidelines (E6 R2/R3, Q9) and GCP standards.
- Practical knowledge of eClinical platforms (EDC, eTMF, CTMS, RTSM/IWRS) and Cloud/SaaS environments.
- Languages: Advanced English (fluent written and verbal communication for general interactions).

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

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📌 Quality Assurance Specialist – IT Compliance & CSV (Pharma/CRO) (Ciudad de México)
🏢 Cohortias - The CRO of Latin America
📍 Ciudad de México