Quality Inspection Readiness Director

Role Summary

Quality Inspection Readiness Director plays a key role in supporting sites to meet regulatory standards and maintain inspection readiness across a global organization. You will collaborate with cross-functional teams, provide expert guidance, and drive continuous improvement in compliance processes.

Responsibilities

• Support GSK sites/related functions that are inspected by key regulators to be inspection ready through Inspection Readiness Pre, During and Post Inspection activities (including PAI inspection readiness)
• Pre-Inspection ‚Äì Prepare for, conduct and manage Inspection Readiness support activities/Assessments of sites utilizing a risk-based approach
• Prepare clear and objective assessment reports communicating inspection readiness risks and implementing corrective action plans
• During Inspection ‚Äì Provide SME coaching, Control Room and Inspection Room Support
• Post Inspection ‚Äì Review regulatory responses, perform Global Assessments, participate in After Action Reviews, and initiate Multisite Commitment actions if needed
• Serve as a business partner to enhance risk management capabilities and share good practices
• Support site capability building through training and coaching of site SMEs in preparation for GMP regulatory Inspections
• Review and check CAPA for key regulatory inspections before next site inspection
• Attend internal GMP/GDP forums and provide recommendations to maintain compliance and advance use of new technology
• Provide interpretation to project teams on regulations, guidelines, compliance status, and policies

Qualifications

• Required: Bachelors degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies

Preferred

• Knowledge of global cGMPs and regulatory requirements; experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, sterile
• Experience in identifying Regulatory Inspection Risks
• Expert knowledge in specific pharmaceutical dose forms or technologies, APIs, manufacturing processes and regulatory submissions
• Familiarity with Primary, Secondary manufacturing and Biopharmaceuticals, sterile manufacturing
• Knowledge of analytical and manufacturing technologies, engineering practices, validation and GMP compliance
• Knowledge of risk management principles and corporate governance processes
• Experience in incident management and resolving quality issues
• Demonstrated improvement in processes related to inspection readiness

Skills

• Regulatory compliance
• GMP and GDP guidance
• Inspection readiness
• Risk assessment and CAPA management
• Training and coaching
• Regulatory liaison and stakeholder management
• Project interpretation of regulations and guidelines