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 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 a
Quality 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) 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 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, 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 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 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 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