Senior QA Specialist Job – Emmes Group | Apply Today!
Looking for a career in clinical research quality assurance? Emmes Group, a leader in clinical trials and medical research, is hiring a Senior Quality Assurance (QA) Specialist in Bengaluru, India. If you have experience in compliance management, auditing, and computer system validation, this is your opportunity to contribute to cutting-edge research that transforms patient care. Apply today and be part of a company that drives medical innovation!
Overview of Emmes Group
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry-leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We believe the work we do will have a direct impact on patient’s lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people-driven company. We’re looking for talented professionals eager to help advance clinical research as we work
to embed innovation into the fabric of our company.Job Details:
- Job Posting: Senior Quality Assurance Specialist
- Location: India – Bengaluru
- Department: Quality Assurance
- Job Type: Regular Full-Time
- Job ID: 2294
Primary Purpose
The Senior QA Specialist assists QA management in guiding the direction of the Quality Management System. This individual works with project and department leaders to assist projects and departments with adherence to applicable regulations, industry standards, and project requirements. The Senior QA Specialist mentors less experienced team members.
Clinical Role
The Senior Quality Assurance Specialist supports the QA Department by conducting internal and vendor audits, assisting with client audits and regulatory inspections, and supporting Quality Management System compliance management.
Computer System Validation Role
The Senior Quality Assurance Specialist will support Emmes’ proprietary and commercial off-the-shelf (COTS) software systems used in clinical trials, as well as IT security deliverables.
Responsibilities
- Conducts internal audits of projects, processes, clinical sites, monitors, deliverables, and departments of moderate to complex scope.
- Reviews documentation for accuracy and compliance.
- Leads supplier/vendor qualification and evaluation.
- Leads client audits and regulatory inspections.
- Leads or participates in process improvement projects.
- Assists in or creates audit schedules for one or more portions of the Quality Management System (QMS).
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Education & Experience for Senior QA Specialist Job:
- Clinical QA: Bachelor’s in Life Sciences or related field + 4 years experience, or Master’s + 2 years, or 6+ years of relevant experience.
- CSV QA: Bachelor’s in Computer Science, Software Engineering, or related field + 4 years experience, or Master’s + 2 years, or 6+ years in computer systems/IT security auditing.
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Certifications: Preferred (e.g., CQA, RAC, RQAP, ISO) with 2–3 years of auditing experience.
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Skills & Requirements:
- Experience in regulated environments (GxP, ISO).
- Familiarity with SDLC validation tools (SAST, DAST) for security testing.
- Strong organizational, multitasking, and problem-solving skills.
- Ability to prioritize tasks and handle unexpected challenges.
- Proficiency in Microsoft Office.
Keywords: Quality Assurance Specialist, Clinical Research, QA Department, Computer System Validation, Auditing, Compliance Management, Senior QA Specialist Job
