Associate Director, GCP QA

Shionogi Inc. (U.S.)

. Provide senior-level quality oversight of clinical trial conduct and clinical development activities .

Posted 10/13/2026full-timeFlorham Park • New Jersey • United StatesSenior💰 $160,000 - $190,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Quality Assurance and Compliance within clinical development, with a strong focus on GCP regulations, audit management, and CAPA implementation. Proven ability to influence cross-functionally and manage vendor quality oversight while ensuring regulatory alignment and patient safety.

Highest-signal resume keywords

Quality Assurance ManagementGCP Compliance ExpertiseAudit Planning and ExecutionCAPA ManagementRegulatory Inspection Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP RegulationsRoot Cause AnalysisQuality AgreementsRisk Mitigation StrategiesClinical Trial Documentation EvaluationAudit ManagementRegulatory AlignmentQuality OversightClinical Development ActivitiesVendor Quality Oversight

Soft Skills

Analytical SkillsDecision-MakingCross-Functional CollaborationCommunication SkillsInterpersonal Awareness

Industry Keywords

ICHFDAEMAMHRAPMDAClinical TrialsGCP AuditsClinical DevelopmentQuality StandardsRegulatory Compliance

About the role

Key responsibilities & impact

Provide senior-level quality oversight of clinical trial conduct and clinical development activities
Serve as QA representative and advisor to assigned clinical study teams
Evaluate clinical trial documentation, processes, and study plans for regulatory alignment
Interpret and resolve GCP compliance issues affecting clinical trial development
Develop, execute, and maintain risk-based GCP audit plans
Plan, conduct, and manage audits of investigator sites, CROs, vendors, phase I units, laboratories, internal processes, and systems
Follow up on audits and ensure timely closure with effective CAPAs
Prepare Shionogi for GCP regulatory inspections and provide inspection support
Manage quality investigations, deviations, root cause analyses, and CAPA implementation
Evaluate CAPA effectiveness through timely closure
Act as key Quality contact for assigned external vendors
Develop and execute Quality Agreements
Assess vendor risks and implement risk mitigation strategies protecting product quality, study compliance, data integrity, and patient safety
Support development, review, and update of QA standards and standards impacting Clinical
Provide GCP feedback on relevant training materials
Influence cross-functionally and across geographies while independently executing audits, inspections, and investigations
Perform other duties as assigned

Requirements

What you’ll need

BA/BS in life sciences, a scientific, technical discipline, or a related field
7+ years of progressive experience in Quality Assurance, Compliance, or Regulatory roles supporting GCP in clinical development
Strong working knowledge of global GCP regulations and guidelines, including ICH, FDA, EMA, MHRA, PMDA, and other local authorities
Experience planning, conducting, and/or managing audits of investigator sites, CROs, vendors, and internal processes
Direct experience supporting global regulatory inspections
Background in CAPA management, root cause analysis, and vendor quality oversight
Experience executing Quality Agreements
Ability and willingness to travel up to 25% of the year domestically and internationally
Must live a commutable distance to the US Corporate Headquarters in Florham Park, NJ
Office presence required 50% per month, at least 2–3 days per week
Strong analytical and decision-making skills
Effective cross-functional and external partner/vendor collaboration
Excellent written and verbal communication skills
Ability to manage multiple priorities, audits, and projects within agreed timelines
Ability to operate autonomously and exercise judgment in escalating issues
Strong interpersonal awareness, adaptability, and resilience in ambiguous or changing environments

Benefits

Comp & perks

Bonus
Long-term incentive
Applicable allowances
Comprehensive benefits
Equal opportunity employment
Reasonable accommodations for qualified individuals with disabilities and disabled veterans