Auditor, RDQA Clinical Quality Audit

Lifelancer

. Execute the Clinical audit program, including scheduling, planning, reporting, and resolution of Clinical audits .

Posted 9/30/2026full-timeRemote • New Jersey • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Audit execution, including scheduling, planning, and reporting, while ensuring compliance with GCP regulations and quality assurance standards. Possesses strong analytical skills and the ability to communicate audit results effectively to support continuous improvement initiatives.

Highest-signal resume keywords

Clinical Audit ExecutionGCP Regulatory SupportQuality AssuranceAnalytical SkillsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical AuditQuality AssuranceGCP ComplianceData AnalysisCorrective Action PlansClinical Research DevelopmentRegulatory Authority ExperienceQuality System DevelopmentContinuous ImprovementClinical Trial Regulations

Soft Skills

Interpersonal SkillsCommunication SkillsFlexibilityTeam CollaborationIndependence

Industry Keywords

Biopharmaceutical IndustryICH-GCPEU Clinical Trial DirectiveQuality StandardsClinical Guidelines

About the role

Key responsibilities & impact

Execute the Clinical audit program, including scheduling, planning, reporting, and resolution of Clinical audits
Ensure alignment with RDQA policies and procedures
Contribute to development and implementation of the Clinical QA quality system
Provide advice and support on GCP and quality topics to business partners
Evaluate Clinical processes through audits and QA oversight activities to assure quality and compliance
Lead and participate in Clinical Audit scheduling, planning, and conduct activities
Conduct investigator clinical site, process, system, and Affiliate audits
Communicate audit results orally and in writing within target timeframes
Review and approve Corrective Action Plans and track actions to completion
Contribute to development and implementation of systems and processes supporting global quality assurance requirements
Support maintenance or development of Quality standards relating to Clinical audit
Contribute to continuous improvement initiatives and projects
Participate in and support GCP inspections as required
Provide GCP regulatory support and consultation to RDQA and business partners
Promote continuous education on quality, clinical guidelines, and regulations

Requirements

What you’ll need

Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy), or equivalent experience
3–5 years of experience in the biopharmaceutical industry or with a regulatory authority
3–5 years of experience in Quality Assurance and/or Clinical Research Development
Strong analytical skills and ability to draw conclusions from presented data
Ability to work effectively and efficiently in a dynamic environment with minimal supervision
High-level awareness and understanding of clinical trial regulations, including ICH-GCP and EU Clinical Trial Directive/Regulation, and industry best practices
Flexibility to adapt to changing assignments and prioritize effectively
Good project management, interpersonal, and communication skills
Ability to work independently and as part of a team
Willingness and ability to perform international travel
Travel up to 40%
Equivalent experience may substitute for the stated bachelor’s degree

Benefits

Comp & perks

Paid time off (vacation, holidays, sick)
Medical, dental, and vision insurance
401(k)
Short-term incentive programs
Equal opportunity employer benefits and reasonable accommodation support for eligible applicants