Quality Assurance – Computer System Validation (CSV) - Pharmaceutical/Biotechnology

Master Compliance; United States; Remote; USD 85,000 - 95,000; Full time

Job summary

A leading company in the Pharmaceutical/Biotechnology sector is seeking a Contractor for Quality Assurance in Computer System Validation (CSV). This role involves supporting SAP-related projects by ensuring compliance and validating GxP computer systems. Candidates should have a strong background in the relevant industry with extensive experience in quality assurance practices.

Qualifications

• Minimum 6 years of experience in the pharmaceutical, biotech, or related regulated industry.
• At least 3 years of hands-on experience in GxP Computer System Validation (CSV).
• Experience in SAP-related projects is required.

Responsibilities

• Write, review, and approve CSV documentation, including Validation Plans.
• Lead or participate in meetings with stakeholders on validation deliverables.
• Serve as QA CSV point of contact and Subject Matter Expert for assigned systems.

Skills

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor’s degree in a technical, scientific, or relevant field

Tools

Microsoft Office

Project management tools

Job description

Quality Assurance – Computer System Validation (CSV) - Pharmaceutical/Biotechnology

Quality Assurance – Computer System Validation (CSV) - Pharmaceutical/Biotechnology

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JOB TITLE: Contractor, Quality Assurance – Computer System Validation (CSV)

DEPARTMENT: Quality

Location: Remote

JOB SUMMARY

The Contractor, Quality Assurance – Computer System Validation (QA CSV), supports ongoing SAP-related projects by collaborating with cross-functional internal teams—such as Supply Chain, Regulatory, IT, and Quality—as well as external vendors and implementation partners. This role is critical in executing and ensuring the validation of GxP computer systems, maintaining regulatory compliance, and contributing to quality risk management.

This position also supports quality processes including deviations, change controls, impact assessments, and periodic reviews, all aligned with applicable regulatory requirements.

ESSENTIAL FUNCTIONS

• Write, review, and approve CSV documentation, including Validation Plans, Functional Risk Assessments, Design/Configuration Specifications, and Test Scripts.
• Lead or participate in meetings with stakeholders, providing expertise on validation deliverables and processes.
• Serve as QA CSV point of contact and Subject Matter Expert (SME) for assigned GxP computer systems.
• Perform or assist in quality reviews and QA vendor audits related to computer systems.
• Manage or oversee external CSV resources as needed.
• Review System Master Plans for compliance with corporate standards.
• Execute GxP-related activities in alignment with business and regulatory requirements.
• Apply evolving validation standards to CSV activities appropriately.
• Contribute to or author Standard Operating Procedures (SOPs) and training materials related to GxP system validation and usage.
• Collaborate closely with IT and system vendors to leverage appropriate user/design documentation and testing artifacts.
• Interpret and apply CSV regulations, guidelines, and best practices in SaaS, cloud-based, and SAP user environments.
• Support development of GxP/Non-GxP deliverables, including SOPs, policies, and work instructions.

QUALIFICATIONS

Education & Experience

• Bachelor’s degree in a technical, scientific, or relevant field.
• Minimum 6 years of experience in the pharmaceutical, biotech, or related regulated industry.
• At least 3 years of hands-on experience in GxP Computer System Validation (CSV).
• Experience in SAP-related projects is required.

Knowledge, Skills & Abilities

• Applied understanding of GxP, GMP, GAMP, 21 CFR Part 11, Annex 11, ICH Q9, and related CSV guidance.
• Thorough understanding of FDA and ICH regulations (GCP, GLP, GMP).
• Proven ability to lead CSV activities independently or in teams.
• Experience collaborating with cross-functional teams and external vendors.
• ASQ CQA certification is preferred but not mandatory.
• Strong influence and communication skills without direct authority.
• Proficient in Microsoft Office and project management tools.
• Excellent verbal and written communication.
• Capable of managing multiple priorities in a fast-paced, matrixed environment.
• Strong analytical and problem-solving skills.
• Effective in planning, organization, and time management.

ADDITIONAL INFORMATION

• Travel Requirements: None
• Physical Requirements: Standard remote office work

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care

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