We are hiring a Quality Assurance Specialist – IT Compliance & CSV (Pharma/CRO)AtCohortias , we are looking for a specialized QA professional to oversee our technology ecosystem.
This isnot a traditional clinical or manufacturing QA role , nor a general IT position—we are seeking an expert in Gx P Computerized System Validation (CSV), data integrity, and technology governance within the pharmaceutical or CRO industry.
Location: Mexico City (Hybrid Model)
About the Role:As aQuality Assurance Specialist (Gx P 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 e Clinical platforms, cloud infrastructure, and software providers comply with international regulations (FDA, EMA) and Gx P standards throughout their lifecycle.
Key Responsibilities:Provide independent QA oversight for the validation lifecycle of Gx P computerized systems (CSV/CSA) underGAMP 5guidelines.
Monitor and evaluate compliance with electronic records and signatures regulations ( 21 CFR Part 11andEU Annex 11 ).
Conduct risk-based quality audits and evaluations covering information security (ISO *****), data privacy (GDPR), and business continuity (ISO *****) for IT and e Clinical technology vendors.




Oversee IT/Gx P vendor qualification, Quality Agreements, SLAs, and change control processes.
Review and approve root cause analyses (RCA), deviations, andCAPAplans 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 experiencestrictly within the pharmaceutical, biotech, medical device, or CRO industry.
Specialization:At least 2 years of hands-on experience in Gx P 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 ofGAMP 5 ,21 CFR Part 11 ,EU Annex 11 , andALCOA+ / ALCOA++data integrity frameworks.
Solid understanding of ICH guidelines (E6 R2/R3, Q9) and GCP standards.
Practical knowledge of e Clinical platforms (EDC, e TMF, CTMS, RTSM/IWRS) and Cloud/Saa S environments.
Languages:Advanced English (fluent written and verbal communication for integral interactions).
Interested in this role or know someone who is a great fit?

📌 Quality Assurance Specialist – It Compliance & Csv (Pharma/Cro) (Nezahualcóyotl)
🏢 Cohortias - The CRO of Latin America
📍 Nezahualcóyotl