Sr. GxP Validation Consultant

Sr. GxP Validation Consultant Robert Half - 3.9 Cincinnati, OH Job Details Temporary | Contract $65 - $75 an hour 20 hours ago Benefits Disability insurance Dental insurance 401(k) Vision insurance Qualifications Data integrity assurance Internal controls Quality records maintenance Requirements specification Requirements design GxP Digital signature usage

FDA 21 CFR

Part 11 IT compliance audits Data summary reports Information security compliance Data integrity and documentation Pharmaceutical company experience System validation Compliance documentation Quality compliance management IT control testing Requirements management Test Execution (Quality assurance practices) Due diligence Access control management Regulatory compliance analysis Identity and access management (IAM) solutions Security control testing Senior level Test validation method Risk assessment implementation Information security auditing Active Directory Validation design Full Job Description 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. 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. Technology Doesn't Change the World, People Do. ® Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles. Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app and get 1-tap apply, notifications of AI-matched jobs, and much more. All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits 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. Visit roberthalf.gobenefits.net for more information. © 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking "," you're agreeing to Robert Half's Terms of Use and Privacy Notice .