Senior Clinical QA Specialist

This is a fully remote position, open to applicants in Argentina, +5 more states.

📋 Description

• We are looking for a senior QA specialist to take on a vital role in ensuring compliance and quality within the organization’s biometric services and computer systems.

• This position requires hands-on execution of QA activities, leadership in audits and risk management, and close collaboration with cross-functional teams including data management, biostatistics, statistical programming, software development and validation, as well as IT and security.

• The senior QA specialist will guarantee that processes, computer systems, and deliverables comply with GxP, ICH-GCP, 21 CFR Part 11, and other relevant regulations, in addition to internal quality standards through proactive oversight, documentation review, system validation, and ongoing process improvement.

• Conduct and/or facilitate internal audits and vendor audits.

• Review and audit the Trial Master File (TMF) to ensure completeness, accuracy, and compliance.

• Track and report on audit findings, deviations, and CAPAs (Corrective and Preventive Actions).

• Perform risk-based audit planning and readiness assessments for inspections.

• Review and assist in the development of policies, SOPs, work practice documents, forms, and other Quality Management System (QMS) documents.

• Ensure alignment with the company’s Quality Policy and applicable external regulations.

• Ensure that controlled documents are reviewed periodically and promptly.

• Document and manage deviations, nonconformances, and CAPAs.

• Maintain quality records and support archiving in line with regulatory timelines.

• Collaborate with functional managers to establish and regularly review training curricula, including study-specific training for internal teams.

• Monitor overdue training and follow up with individuals and their supervisors until completion.

• Engage in validation planning and execution for both internal and customer-facing systems.

• Work with the software validation team and IT to review the computer system validation plan (CVP), functional/user requirements specifications, and risk assessments.

• Plan, execute, and document internal process audits, project/study audits, and vendor audits.

• Coordinate with biometric teams to ensure services comply with applicable regulations and EDETEK SOPs, including adherence to QC processes, proper document versioning, review and approval, as well as appropriate documentation and sign-off for deviations.

• Lead or assist in preparation for regulatory audits (e.g., FDA, EMA, MHRA).

⛳️ Requirements

• Strong ability to communicate effectively in English, both spoken and written.

• Competence to work independently, take initiative, and meet deadlines.

• Capable of prioritizing and executing tasks in a high-pressure environment.

• Demonstrated ability to collaborate across diverse teams and functions.

• Adaptable and productive in a dynamic and evolving environment.

• Proficient with Microsoft Office applications.

• Bachelor's degree in life sciences, computer science, or a related field.

• At least 5 years of QA experience in clinical research, clinical systems, or regulated software environments.

• Strong understanding of GxP, ICH-GCP, 21 CFR Part 11, Annex 11, and SDLC principles.

• Proven experience in conducting audits and managing CAPAs.

• Excellent documentation and communication skills.

• Preferred: Experience in an organization providing eClinical or biometric services.

• Preferred: Familiarity with electronic QMS platforms such as ZenQMS.

🏝️ Benefits

• Benefits vary by country but are competitive. Below is a sample of the benefits offered to U.S. employees.

• Choice of comprehensive Medical, Vision, and Dental Insurance plans.

• Paid vacation time and sick days.

• Corporate holidays each year.

• Participation in the 401K Plan.

• Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, and more.

• Health Advocate and Employee Assistance Program.