Senior CSV Specialist CRO

Join MMS, an award-winning clinical research organization, as a Senior Quality Assurance Specialist – CSV. At MMS, your expertise in Computer System Validation will directly impact the quality and compliance of clinical research systems supporting pharmaceutical, biotech, and medical device industries. Enjoy a collaborative, innovative work environment with a global footprint and industry-leading employee retention.

Job Overview

Lead and execute CSV activities across clinical systems, ensuring compliance with GxP, 21 CFR Part 11, and regulatory standards. Act as a subject matter expert, mentor team members, and contribute to the continual improvement of quality management processes. Collaborate with cross-functional teams and support audits, documentation, and SOP development.

Key Responsibilities

• Lead and support Computer System Validation (CSV) activities for clinical systems (e.g., EDC, CTMS, LIMS).
• Create, review, and manage validation documents, including Validation Plans, Test Scripts, Traceability Matrices, and Reports.
• Ensure strict compliance with GxP, 21 CFR Part 11, and related regulatory guidelines.
• Collaborate with IT, QA, and functional leads to align on quality and regulatory expectations.
• Participate in audits and inspections, providing documentation support and addressing findings.
• Develop and maintain SOPs, risk assessments, and contribute to periodic reviews.
• Monitor vendors for adherence to CSV processes and quality standards.
• Mentor and advise team members on regulatory updates and best practices.

Required Skills & Qualifications

• Graduate degree in a scientific, medical, or clinical discipline (Master’s preferred) or equivalent experience.
• 7-10 years of hands-on experience in Computer System Validation within clinical research or pharmaceutical domains.
• Deep knowledge of GAMP 5, GxP, 21 CFR Part 11, and related regulations.
• Proven ability to author and manage QMS documents (SOPs, Work Practices, Forms, Training Materials).
• Strong documentation, communication, and organizational skills with attention to detail.
• Ability to multitask, proactively identify risks, and resolve audit findings.
• Familiarity with RegTech systems or electronic document management systems (EDMS) is advantageous.
• Experience supporting internal process audits and collaborating cross-functionally.