Sr. GxP Validation Consultant

We are looking for an experienced Sr. GxP Validation Consultant to support regulated technology and compliance initiatives. This Long-term Contract opportunity is suited for a detail-oriented individual who can lead validation efforts for controlled environments, with particular strength in Active Directory validation and computerized system compliance. The ideal candidate will bring deep knowledge of GxP expectations, data integrity standards, and electronic records and signatures requirements while partnering closely with quality and IT stakeholders to maintain inspection-ready documentation and processes.

Responsibilities:

• Lead validation activities for Active Directory and related regulated technology environments, ensuring documented evidence supports fitness for intended use.

• Develop and maintain lifecycle deliverables such as requirements, risk assessments, test protocols, traceability records, summary reports, and periodic review documentation.

• Interpret applicable GxP regulations and convert compliance expectations into practical procedures, controls, and validation records that withstand audit scrutiny.

• Assess and verify key system controls including user access management, audit trail functionality, and electronic signature compliance within validated environments.

• Apply risk-based validation principles to prioritize testing scope, justify validation decisions, and support ongoing control of regulated systems.

• Partner with Quality Assurance, IT, and business teams to coordinate validation planning, issue resolution, and sustained compliance activities.

• Support inspection and audit readiness by organizing evidence, answering validation-related questions, and helping address observations or gaps.

• Produce clear compliance documentation and reports that reflect regulatory expectations, internal standards, and current validated-state requirements.

Qualifications:

• Proven experience validating Active Directory environments within GxP-regulated settings.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, and core expectations for electronic records, electronic signatures, and controlled system operation.
• Hands-on experience executing the full validation lifecycle, including requirements definition, test execution, deviation handling, and maintenance of validated status.
• Solid understanding of data integrity concepts and system control requirements such as audit trails, role-based access, and security administration.
• Ability to translate regulatory and compliance requirements into actionable documentation, procedures, and risk-based validation strategies.
• Experience collaborating with QA and IT stakeholders in regulated industries; pharmaceutical industry background is preferred.
• Capability to support audits or inspections through well-structured documentation, due diligence, and effective written reporting.

Compensation

$65.00-$75.00 Hourly

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