Quality Inspection Readiness Director

Role Summary

Quality Inspection Readiness Director. You will play a key role in supporting sites to meet regulatory standards and maintain inspection readiness every day. 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 - Prepare for, conduct and manage Inspection Readiness support activities/Assessments of sites utilizing a risk-based approach.
• Preparation of clear and objective assessment reports that communicate inspection readiness risks to senior management and ensure appropriate corrective action plans are implemented.
• During Inspection ‚Äì Provide support for key Regulatory Inspections (e.g., SME coaching, Control Room and Inspection Room Support).
• Post Inspection ‚Äì Review the regulatory response, perform Global Assessments, participate in After Action Reviews, and initiate Multi-Site Commitment actions if needed.
• Act as a business partner to enhance risk management capabilities and share good practices and improvement opportunities.
• 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 to ensure they are closed out effectively.
• Attend internal forums as GMP/GDP expert, providing recommendations for continued compliance and for adoption of new technologies.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status and policies.

Qualifications

• Required: Bachelor's degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
• Preferred: Knowledge of world-wide cGMPs and regulatory requirements; experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, sterile; proficiency in identifying Regulatory Inspection Risks; demonstrated expertise in specific pharmaceutical dose forms or technologies, APIs, manufacturing processes and regulatory submissions.

Skills

• Regulatory inspections and GMP/compliance expertise
• Risk assessment and CAPA management
• Training and coaching of SMEs for inspections
• Regulatory liaison and cross-functional collaboration
• Documentation and reporting of inspection readiness

Education

• Bachelors degree (required). Additional advanced degree or certifications in quality/regulatory fields are a plus.

Additional Requirements

• Hybrid role; travel up to 50% and proximity to a GSK site.