Senior CSV Specialist CRO

New

Skills

Audit Clinical Research Communication Documentation QA Risk Assessment

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.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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