Director, GCP Inspection Management – Americas

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee activities to ensure inspection readiness and coordinate GCP inspections conducted by regulatory health authorities.

• Create, sustain, and implement a risk-based, proactive GCP Inspection Strategy.

• Ensure the development of inspection risk analyses and risk-mitigation plans, communicating them to cross-functional and Quality Leadership.

• Supervise and manage collaboration with both internal and external cross-functional partners.

• Ensure the development, revision, and maintenance of tools, processes, and procedures for inspection readiness, coordination, and management.

• Lead Quality professionals and/or consultants in GCP inspection readiness, management, and hosting activities.

• Oversee the fulfillment of inspection commitments, communication with Inspectorates/Health Authorities, addressing inspection findings, managing inspection dossiers, pre-inspection requests, and ensuring CAPA closure.

• Maintain a forecast of inspections and track inspection outcomes.

• Lead sessions to capture lessons learned post-inspection and identify trends and best practices for process enhancement.

• Chair quarterly meetings for the Cross-functional Inspection Oversight Committee.

• Guide and/or manage the creation and revision of relevant procedures.

• Review trends and report significant issues related to investigations, deviations, and system deficiencies to senior management.

• Manage the internal training program and coordinate/administer GxP training.

• Represent R&D Quality in various meetings and discussions.

• Act as the R&D Quality Delegate for the Executive Director, R&D Quality, when necessary.

• Assist in developing metrics and measures for inspection data aimed at continuous improvement.

• Participate in budget forecasting, planning, and tracking activities.

• Mentor and coach team members while supporting the onboarding and qualification of new Quality staff.

• Foster a culture of continuous improvement.

• Support the GCP Inspection Management Team with other types of inspections, including GLP and PV inspections.

• Perform additional duties as assigned.

⛳️ Requirements

• A minimum of 10 years of experience in the pharmaceutical/biotechnology industry.

• At least 5 years of experience in supporting GCPs and managing/hosting GCP inspections.

• 10+ years of experience with a Bachelor’s degree, preferably in Science, or a Master's degree with 7+ years of experience.

• A strong global mindset with knowledge of regulations and specific expertise in compliance requirements and cultural awareness.

• Comprehensive understanding of international regulations applicable to clinical trials.

• Proven ability to establish strategies for and lead quality process improvement initiatives.

• Strong leadership, strategic, analytical, mentoring, project management, judgment, and decision-making skills.

• Capable of managing multiple projects and meeting demanding timelines.

• Effective management skills in building and supporting high-performing teams.

• Exceptional attention to detail and excellent review capabilities.

• Ability to organize and manage various tasks in a fast-paced setting.

• Proficient in PC usage.

• Skills in MS Office: Outlook, Word, Excel, and PowerPoint.

• Excellent verbal and written communication abilities.

• Capability to collaborate effectively in a dynamic environment.

• Willingness to travel up to 30% as needed.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Participation in a Voluntary Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) / Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Provision for reasonable accommodations in the job application process.