[Remote] Sr. GxP Validation Consultant

Remote Full-time
Note: The job is a remote job and is open to candidates in USA. Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. They are looking for an experienced Sr. GxP Validation Consultant to support regulated technology and compliance initiatives, focusing on validation efforts for controlled environments and ensuring compliance with GxP expectations.ResponsibilitiesLead validation activities for Active Directory and related regulated technology environments, ensuring documented evidence supports fitness for intended useDevelop and maintain lifecycle deliverables such as requirements, risk assessments, test protocols, traceability records, summary reports, and periodic review documentationInterpret applicable GxP regulations and convert compliance expectations into practical procedures, controls, and validation records that withstand audit scrutinyAssess and verify key system controls including user access management, audit trail functionality, and electronic signature compliance within validated environmentsApply risk-based validation principles to prioritize testing scope, justify validation decisions, and support ongoing control of regulated systemsPartner with Quality Assurance, IT, and business teams to coordinate validation planning, issue resolution, and sustained compliance activitiesSupport inspection and audit readiness by organizing evidence, answering validation-related questions, and helping address observations or gapsProduce clear compliance documentation and reports that reflect regulatory expectations, internal standards, and current validated-state requirementsSkillsProven experience validating Active Directory environments within GxP-regulated settingsStrong knowledge of 21 CFR Part 11, EU Annex 11, and core expectations for electronic records, electronic signatures, and controlled system operationHands-on experience executing the full validation lifecycle, including requirements definition, test execution, deviation handling, and maintenance of validated statusSolid understanding of data integrity concepts and system control requirements such as audit trails, role-based access, and security administrationAbility to translate regulatory and compliance requirements into actionable documentation, procedures, and risk-based validation strategiesExperience collaborating with QA and IT stakeholders in regulated industries; pharmaceutical industry background is preferredCapability to support audits or inspections through well-structured documentation, due diligence, and effective written reportingExperience collaborating with QA and IT stakeholders in regulated industries; pharmaceutical industry background is preferredBenefitsBenefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance.Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan.Company OverviewDice is the go-to career marketplace for tech professionals. It was founded in 2010, and is headquartered in Drachten, Friesland, NLD, with a workforce of 201-500 employees. Its website is https://www.or-quest.nl/.

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