Director, GCP Inspection Management – Americas

BeOne Medicines

. Supervise inspection readiness activities and host and coordinate GCP inspections conducted by regulatory health authorities .

Posted 10/9/2026full-timeRemote • United StatesLead💰 $172,000 - $232,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in GCP inspection management and quality process improvement within the pharmaceutical and biotechnology sectors. Proven ability to lead cross-functional teams, develop inspection strategies, and ensure compliance with international regulations.

Highest-signal resume keywords

GCP Inspection ManagementQuality Process ImprovementRegulatory ComplianceProject ManagementTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP RegulationsRisk AnalysisInspection ReadinessCAPA ManagementData Metrics DevelopmentBudget ForecastingProcess ImprovementTraining Program ManagementInspection Dossier ManagementQuality Assurance

Soft Skills

LeadershipAnalytical SkillsMentoringCommunication SkillsAttention to Detail

Tools & Technologies

MS OfficeInspection Outcome TrackerGxP Training Tools

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryClinical TrialsGLP InspectionsPV Inspections

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Supervise inspection readiness activities and host and coordinate GCP inspections conducted by regulatory health authorities
Develop, maintain, and ensure execution of a risk-based, proactive GCP Inspection Strategy
Ensure development of inspection risk analyses and risk-mitigation plans and communicate them to cross-functional and Quality Leadership
Supervise and manage collaboration with cross-functional internal and external partners
Ensure development, revision, and maintenance of tools, processes, and procedures for inspection readiness, coordination, and management
Lead Quality professionals and/or consultants conducting GCP inspection readiness, management, and hosting activities
Oversee fulfillment of inspection commitments, communications with Inspectorates/Health Authorities, inspection findings, inspection dossiers, pre-inspection requests, and CAPA closure
Maintain an inspection forecast and inspection outcome tracker
Lead post-inspection lessons-learned sessions and identify trends and best practices for process improvement
Chair quarterly Cross-functional Inspection Oversight Committee meetings
Guide and/or manage creation and revision of procedures
Review trends and report significant investigation, deviation, and system deficiency issues to senior management
Manage the internal training program and coordinate/administer GxP training
Represent R&D Quality in meetings and discussions
Act as R&D Quality Delegate for the Executive Director, R&D Quality, as needed
Support development of inspection data metrics and measures for continuous improvement
Participate in budget forecasting, planning, and tracking
Coach and mentor team members and support onboarding and qualification of new Quality staff
Promote continuous improvement
Support the GCP Inspection Management Team with other inspection types, including GLP and PV inspections
Perform other duties as assigned

Requirements

What you’ll need

10+ years of experience in the pharmaceutical/biotechnology industry
5+ years of experience supporting GCPs and managing/hosting GCP inspections
10+ years with a Bachelor’s degree, preferably in Science, or MS with 7+ years
Strong global mindset and knowledge of regulations, specific expertise in regulations/requirements/cultural awareness
Strong global knowledge and understanding of international regulations applicable to clinical trials
Proven ability to set strategy for and drive quality process improvement initiatives
Strong leadership, strategic, analytical, mentoring, project management, judgment, and decision-making skills
Ability to manage multiple projects and demanding timelines
Effective management skills in building and supporting highly effective teams
Superb attention to detail and excellent review skills
Ability to organize and manage multiple tasks in a fast-paced environment
PC literacy required
MS Office skills: Outlook, Word, Excel, and PowerPoint
Excellent verbal and written communication skills
Ability to effectively collaborate in a dynamic environment
May require up to 30% travel

Benefits

Comp & perks

Annual bonus plan eligibility for non-commercial roles
Incentive compensation plan eligibility for commercial roles
Discretionary equity awards
Voluntary Employee Stock Purchase Plan participation
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life insurance
Paid Time Off
Wellness benefits
Reasonable accommodation in the job application process