Senior Quality Assurance Specialist

Senior Quality Assurance Specialist (LATAM Remote)

Emmes Group is a leading clinical research provider, transforming the future of clinical research and bringing new medical discovery closer to patients. We build industry‐leading capabilities in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. We are passionate about having a direct impact on patients’ lives and fostering a performance‑driven, people‑centric culture.

The Senior QA Specialist is a member of the Quality Assurance department and assists QA management in ongoing management of the Quality Management System (QMS). Responsibilities include conducting internal and vendor audits, leading client audits, supporting regulatory inspections, and overseeing issue management and controlled document management. The Senior QA Specialist collaborates with project and department leaders to ensure adherence to applicable regulations, industry standards, and project requirements, while mentoring less experienced team members.

• Conduct internal audits of projects, processes, clinical sites, deliverables and departments of moderate to complex scope.
• Review documentation for accuracy and compliance (e.g., training records, CAPAs, quality incidents, audit reports, computer system validation packages).
• Track non‑compliances, deviations, and CAPAs.
• Lead supplier/vendor qualification and evaluation.
• Lead client audits and regulatory inspections.
• Lead or participate in process improvement projects.
• Assist in or create audit schedules for one or more portions of the QMS.
• Write and review Quality SOPs and policies.
• Conduct trainings on quality topics, as assigned.
• Provide guidance or mentorship to less experienced team members as a subject matter expert.
• May have day‑to‑day oversight of some QMS activities or functions.
• Represent the QA department at meetings or events with nominal assistance from Quality Management.
• Contribute to solutions for corporate and global QA initiatives and tasks.
• Perform other duties as assigned.

• Bachelor’s degree in Life Sciences or a related scientific field and 4–6 years of related experience.
• Experience working in a regulated environment (e.g., GxP, ISO).
• Knowledge and understanding of GxP regulatory requirements and implementation (FDA, EU, ICH, country‑specific regulations and relevant guidance).
• For computer system validation roles: knowledge of 21
  
  CFR Part 11/EU Annex 11, GAMP 5, and related industry standards; familiarity with security regulations such as NIST SP 800‑53 and FISMA preferred.
• Quality certifications preferred (e.g., CQA, RAC, RQAP, ISO).
• Experience with Veeva preferred.

Mexico City, Bogotá, São Paulo, Panama City – LATAM Remote.

Employment type:

Full‑time. Seniority level:
Mid‑Senior level. Job function:
Quality Assurance / Research Services.

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