Senior Manager, GCP/GVP

Shionogi Inc. (U.S.)

. Support and maintain a robust GVP and GCP compliance program across the organization, with GVP QA as the primary responsibility and GCP QA as the secondary responsibility .

Posted 10/5/2026full-timeFlorham Park • New Jersey • United StatesSenior💰 $135,000 - $165,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GVP and GCP compliance, including the development and maintenance of Quality Management Systems and regulatory oversight. Proven ability to manage audits, ensure compliance with global regulations, and drive continuous improvement in quality systems.

Highest-signal resume keywords

GVP ComplianceGCP CompliancePharmacovigilance System Master File ManagementRegulatory Inspection PreparationAudit Strategy Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GVP RegulationsGCP RegulationsQuality Management System DevelopmentRisk Assessment ManagementCorrective and Preventive Actions (CAPAs)Root Cause AnalysisProject ManagementRegulatory CompliancePharmacovigilanceClinical Study Oversight

Soft Skills

Attention to DetailTeam PlayerCritical ThinkingProblem-SolvingCommunication

Industry Keywords

FDAICHEMAMHRAPMDAQuality AssuranceCompliance ProgramClinical TrialsCross-Functional CollaborationContinuous Improvement

About the role

Key responsibilities & impact

Support and maintain a robust GVP and GCP compliance program across the organization, with GVP QA as the primary responsibility and GCP QA as the secondary responsibility
Collaborate with Global GVP/GCP QA teams to provide quality oversight of pharmacovigilance, business/licensing partners, distributors, clinical studies, CROs/vendors
Engage in the development, implementation, and maintenance of the GVP and GCP Quality Management System
Ensure compliance with worldwide and local PV regulations
Prepare for regulatory inspections, including FDA PADE inspections
Collaborate with Global QA teams to develop and execute audit strategies
Manage, oversee, or conduct audits
Ensure ongoing compliance with relevant GVP and GCP global and local regulatory requirements and guidelines
Manage and support maintenance of Pharmacovigilance System Master Files (PSMF)
Manage compliance with risk assessments
Facilitate root cause analysis
Ensure implementation and effectiveness of Corrective and Preventive Actions (CAPAs) and effectiveness checks
Act as primary GVP Quality contact and assigned GCP Quality contact, collaborating with cross-functional teams and internal departments
Drive continuous improvement of GVP and GCP quality systems and procedures
Perform other duties as assigned

Requirements

What you’ll need

BA/BS in life sciences, a scientific, technical discipline, or a related field
Minimum of 6 years of experience in a GVP/GCP QA/quality/compliance role or regulatory inspectorate role supporting PV and/or clinical study teams
Working knowledge of GVP/GCP regulations and guidelines, including ICH, FDA, EMA, MHRA and PMDA requirements
Strong attention to detail, team player, agile, excellent communication skills, strong critical thinking skills, and effective problem-solving abilities
Excellent project management, organizational, and leadership skills to manage cross-functional teams and multiple projects simultaneously
Capable of operating in an ambiguous environment
Capable of operating independently with a leveled understanding of decision making
Ability and willingness to travel up to 15% of the year both domestically and internationally
Must live a commutable distance to the US Corporate Headquarters in Florham Park, NJ

Benefits

Comp & perks

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