Quality Inspection Readiness Director

Role Summary

Quality Inspection Readiness Director — responsible for ensuring regulatory compliance and inspection readiness across GSK sites. Collaborates with cross-functional teams, provides expert guidance, and drives continuous improvement in compliance processes.

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 and ensuring appropriate corrective action plans are implemented.
• During Inspection: Provide SME coaching, Control Room and Inspection Room Support for 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 for GMP regulatory inspections.
• Review and check CAPA for key regulatory inspections before the next site inspection to ensure closure.
• Attend internal GMP/GDP forums as a expert, offering recommendations to maintain compliance and advance use of new technology.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies.
• Be the point of contact with sites assessed for inspection readiness.
• Propose updates to Global QMS documents and/or local SOPs based on identified gaps.
• Assist in training and coaching of guest assessors; expand knowledge through collaboration.
• Promote excellence and continuous improvement in inspection readiness, best practices, and processes.
• Work with the QMS team on policies and global processes related to Inspection Readiness; participate in IR CoP/Compliance Forum.
• Share learnings from significant Regulatory Inspections across GSC; develop tools to support inspection readiness processes; ensure KPI metrics are in place to support decision-making.

Qualifications

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

Preferred Qualifications

• Knowledge of worldwide cGMPs and regulatory requirements; experience in regulatory inspections, standards, and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, and sterile products.
• Proficiency in identifying Regulatory Inspection Risks.
• Demonstrated expertise in one or more 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 process improvements for inspection readiness.

Skills

• Regulatory compliance and inspection readiness
• GMP, GDP, and regulatory knowledge across multiple regions
• Risk assessment and CAPA management
• Training and coaching of site SMEs and auditors
• Documentation, reporting, and communication with senior management
• Project management and cross-functional collaboration