Remote GxP CSV Validation Lead

QSE7 Consulting; United States; Remote; USD 165.000 - 262.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

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

Ausbildung

Bachelor’s degree in Life Sciences/Engineering/CS

Tools

Kneat

ValGenesis

Jira

Jobbeschreibung

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