Quality Inspection Readiness Director

Role Summary

Quality Inspection Readiness Director. Assists sites to be inspection ready on a daily basis through coaching, training and education, supporting inspections by key regulators (FDA, MHRA, EMA outside Europe, HPRA and China). Collaborates with cross-functional teams, provides expert guidance, and drives continuous improvement in compliance processes within a global organization.

Responsibilities

• Support GSK sites/related functions that are inspected by key regulators to be inspection ready through pre-, during-, and post-inspection activities (including PAI inspection readiness).
• Pre-Inspection: prepare for, conduct, and manage inspection readiness support activities/assessments of sites using a risk-based approach.
• Prepare clear and objective assessment reports communicating inspection readiness risks to senior management and implement appropriate corrective action plans.
• During Inspection: provide SME coaching, control room and inspection room support for key regulatory inspections.
• Post Inspection: review regulatory responses, perform global assessments, participate in After Action Reviews, and initiate multi-site commitments if needed.
• Act as a business partner to enhance risk management and share best practices and improvement opportunities.
• Support site capability building through training and coaching of site SMEs in preparation for GMP regulatory inspections.
• Review and verify CAPA for key regulatory inspections before next site inspection to ensure closure.
• Attend internal GMP/GDP forums to advise on continued compliance and use of new technology in processes.
• Provide interpretation and consultation on regulations, guidelines, compliance status and policies to project teams.

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 global cGMPs and regulatory requirements; experience in regulatory inspections, standards and quality management systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, sterile.

Skills

• Regulatory inspections and risk identification
• GMP compliance, analytical and manufacturing technologies knowledge
• Regulatory guidelines interpretation and project support
• Training and coaching of site SMEs; cross-functional collaboration

Education

• Bachelor's degree (required as part of qualifications)

Additional Requirements

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