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BeOne Medicines
BeOne Medicines
BiotechnologyHealthcarePharmaceuticals
BeOne Medicines is a Switzerland-domiciled global oncology company focused on discovering and developing innovative cancer treatments designed to improve affordability and access. Its portfolio covers hematologic cancers and solid tumors, supported by an expanding pipeline of novel therapeutics advanced through in-house capabilities and external collaborations. With more than 11,000 colleagues across six continents, BeOne Medicines is working to broaden access to medicines for patients worldwide.
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Director of GCP Inspection Management, Americas (Remote)

Lead GCP inspection readiness, hosting, and compliance for BeOne Medicines’ oncology development programs across the Americas. Oversee inspection strategy, Quality teams, CAPA closure, and continuous improvement.

USUnited States
$172,000 – $232,000 / year
RemoteFull-timeLeadEnglish RequiredDirector
Google Cloud Platform

Description

  • Oversee inspection-readiness activities and coordinate the hosting of GCP inspections by regulatory health authorities
  • Create, maintain, and implement a proactive, risk-based GCP inspection strategy
  • Ensure inspection risk assessments and mitigation plans are developed and communicated to Quality leadership and cross-functional stakeholders
  • Direct collaboration with internal and external partners across functions
  • Oversee the creation, revision, and maintenance of inspection-readiness tools, processes, and procedures
  • Lead Quality professionals and consultants responsible for GCP inspection preparation, management, and hosting
  • Monitor inspection commitments, health-authority communications, findings, inspection dossiers, pre-inspection requests, and CAPA completion
  • Maintain inspection forecasts and track inspection outcomes
  • Lead post-inspection lessons-learned reviews and identify trends and effective practices for process improvement
  • Chair quarterly meetings of the Cross-functional Inspection Oversight Committee
  • Provide guidance on, and manage, procedure development and revision
  • Evaluate trends and escalate significant investigation, deviation, and system-deficiency matters to senior management
  • Manage the internal training program and coordinate GxP training delivery
  • Represent R&D Quality in relevant meetings and discussions
  • Serve as delegate for the Executive Director of R&D Quality when required
  • Support the development of inspection metrics and performance measures for continuous improvement
  • Contribute to budget forecasting, planning, and tracking
  • Coach and mentor team members and support the onboarding and qualification of new Quality staff
  • Advance continuous-improvement initiatives
  • Support the GCP Inspection Management Team with GLP, PV, and other inspection types
  • Complete additional responsibilities as assigned

Requirements

  • At least 10 years of experience in the pharmaceutical or biotechnology industry
  • At least 5 years supporting GCP activities and managing or hosting GCP inspections
  • At least 10 years of experience with a bachelor’s degree, preferably in science, or 7+ years with a master’s degree
  • Broad global perspective with strong knowledge of regulations, requirements, and cultural considerations
  • Thorough understanding of international regulations governing clinical trials
  • Demonstrated success setting strategy and driving quality-process improvements
  • Strong leadership, strategic, analytical, mentoring, project-management, judgment, and decision-making capabilities
  • Ability to manage multiple projects against demanding timelines
  • Effective people-management skills for building and supporting high-performing teams
  • Exceptional attention to detail and review capability
  • Ability to organize and oversee multiple priorities in a fast-paced setting
  • Computer proficiency is required
  • Proficiency with Outlook, Word, Excel, and PowerPoint
  • Excellent written and verbal communication skills
  • Ability to collaborate effectively in a changing environment
  • Availability for travel of up to 30% may be required

Benefits

  • Eligibility for an annual bonus plan in non-commercial roles
  • Eligibility for an incentive compensation plan in commercial roles
  • Discretionary equity awards
  • Access to a voluntary employee stock purchase plan
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k) plan
  • Flexible spending and health savings accounts
  • Life insurance
  • Paid time off
  • Wellness programs
  • Reasonable accommodation during the job application process

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