CSV Lead – GxP Systems Validation

QSE7 Consulting; United States; Remote; USD 165,000 - 262,000; Full time

Job summary

QSE7 Consulting, a Pennsylvania-based firm, seeks an experienced Quality Compliance & Validation Lead for a full-time remote contract with a global biotechnology client. You will lead validation of an enterprise system with GxP and non-GxP functionality, determine GxP impact, and define a risk-based validation strategy.

Responsibilities include developing the validation plan and risk assessments with GAMP 5 and CSA, assessing 21 CFR Part 11 and EU Annex 11, and guiding QA, IT, and vendor

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or a related field.
• 8+ years of CSV or IT quality experience in GxP contexts, incl. 3+ years leading validation strategy.
• GxP impact assessments and scoping for mixed GxP/non-GxP systems.
• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, CSA, ALCOA+ expectations.
• Experience validating enterprise/SaaS platforms with integrations and data migration.
• Delivery of full validation lifecycle documents (plans, requirements, risk assessments, tests, reports).
• Change control, deviations, CAPA, and support of audits/inspections.
• CSA in practice and Agile SDLC experience preferred.
• Familiarity with electronic validation tools and platforms (Kneat, ValGenesis, HP ALM, Jira).
• Nice to have exposure to Veeva, SAP, Salesforce.
• Strong communication and stakeholder management; able to work remotely.
• Self-directed, capable of managing multiple priorities remotely.

Responsibilities

• Serve as the accountable validation and compliance lead for an enterprise system with GxP and non-GxP functionality, partnering with QA, IT, business, and vendor stakeholders.
• Perform GxP impact assessments to determine which modules, functions, data, and integrations are GxP-relevant, and document a clear, defensible validation boundary.
• Develop the validation plan and risk assessments using GAMP 5 (Second Edition) and CSA principles, right-sizing validation effort to risk.
• Assess 21 CFR Part 11 and EU Annex 11 applicability, including electronic records, signatures, and audit trails, and evaluate ALCOA+ data integrity risk.
• Define testing approach with scripted testing for high-risk areas and exploratory testing where appropriate, leveraging vendor documentation when justified.
• Author and own validation deliverables including requirements, risk assessments, test protocols, traceability, and summary reports.
• Oversee test execution, review objective evidence, and manage deviations through resolution.
• Conduct supplier and SaaS vendor assessments and classify components by GAMP category.
• Serve as regulatory SME, translating requirements into practical validation guidance.
• Establish change control, periodic review, and release processes to maintain validated state.
• Support audit readiness, presenting validation approach to QA and auditors.
• Align deliverables with client SOPs and the QMS, identifying gaps and remediation.

Skills

CSV experience

Lead validation strategy

GxP impact assessments

Regulatory knowledge

Cloud/SaaS validation

Validation lifecycle

CAPA & audits

CSA & Agile

Electronic validation tools

Veeva/SAP/Salesforce

Stakeholder management

Remote work

Education

Bachelor’s degree in Life Sciences/Engineering/CS

Tools

Kneat

ValGenesis

Jira

Job description

QSE7, a Pennsylvania-based consulting firm, is seeking to hire an experienced Quality Compliance & Validation Lead for a full-time contract engagement with a global biotechnology client. In this role, you will lead the validation of an enterprise system that includes both GxP and non-GxP functionality. You will determine which components carry GxP impact, define a risk-based validation and testing strategy for them, and guide business, IT, and vendor stakeholders on what regulations truly require, ensuring the system remains compliant without unnecessary validation effort. This is a fully remote role with an initial contract term and potential for extension.

Job Responsibilities:

• Serve as the accountable validation and compliance lead for an enterprise system with both GxP and non-GxP functionality, partnering with QA, IT, business, and vendor stakeholders.


• Perform GxP impact assessments to determine which modules, functions, data, and integrations are GxP-relevant, and document a clear, defensible validation boundary.


• Develop the validation plan and risk assessments using GAMP 5 (Second Edition) and Computer Software Assurance (CSA) principles, right-sizing validation effort to the level of risk.


• Assess 21 CFR Part 11 and EU Annex 11 applicability, including electronic records, electronic signatures, and audit trails, and evaluate data integrity risk against ALCOA+ principles.


• Define the testing approach, applying scripted testing for high-risk GxP functions, unscripted or exploratory testing where appropriate, and leveraging vendor documentation where justified.


• Author and own validation deliverables, including user and functional requirements, risk assessments, test protocols, traceability matrix, and validation summary report.


• Oversee test execution, review objective evidence, and manage test deviations through resolution.


• Conduct supplier and SaaS vendor assessments and classify system components by GAMP software category.


• Serve as the regulatory subject matter expert, translating regulatory requirements into practical guidance on what must be validated and why.


• Establish change control, periodic review, and release processes to maintain the GxP portion of the system in a validated state.


• Support audit and inspection readiness, presenting and defending the validation approach to QA and auditors.


• Align deliverables with client SOPs and the QMS, identifying procedural gaps and recommending remediation.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or a related field.


• 8+ years of computer system validation (CSV) or IT quality experience in GxP-regulated pharmaceutical or biotech environments, including 3+ years leading validation strategy.


• Hands-on experience performing GxP impact assessments and scoping validation for systems with both GxP and non-GxP functionality.


• Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 (Second Edition), FDA Computer Software Assurance (CSA), and data integrity (ALCOA+) expectations.


• Experience validating enterprise or SaaS/cloud platforms (e.g., ERP, QMS, LIMS, CRM), including system integrations and data migration.


• Proven ability to deliver full validation lifecycle documentation, including validation plans, requirements, risk assessments, test protocols, traceability, and summary reports.


• Experience with change control, deviations, and CAPA, and direct support of internal audits or regulatory inspections.


• Experience applying CSA in practice and validating within Agile SDLC release cycles is preferred.


• Familiarity with electronic validation tools (e.g., Kneat, ValGenesis, HP ALM, Jira) and platforms such as Veeva, SAP, or Salesforce is a plus.


• Strong communication and stakeholder management skills, with the ability to explain regulatory rationale to non-quality audiences and hold a position under pushback.


• Self-directed and able to operate effectively in a remote environment while managing multiple priorities.

About QSE7

Founded in 2016, QSE7 offers innovative and specialized Information Technology (IT) and Consulting services to FDA-regulated life sciences companies. Our areas of focus include program/project management, process analysis, automated business process improvements, data analytics and reporting, and implementation of IT solutions based on Microsoft technologies, such as Excel, MS Teams, SharePoint, Power BI and Power Automate. We strive to bring automation and efficiency to our clients' processes by providing high-quality and intuitive solutions in an efficient, comprehensive manner.