Quality Inspection Readiness Director

Role Summary

Quality Inspection Readiness Director. Support sites to meet regulatory standards and maintain inspection readiness, collaborating with cross-functional teams, providing expert guidance, and driving continuous improvement in compliance processes. Hybrid role with travel up to 50% and proximity to a GSK site.

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 and assessments using a risk-based approach.
• Prepare clear and objective assessment reports communicating inspection readiness risks and implementing corrective action plans.
• During Inspection: provide SME coaching, Control Room and Inspection Room support.
• 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 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 CAPAs for key regulatory inspections to ensure closure before next inspections.
• Attend internal GMP/GDP forums and provide recommendations to maintain compliance and leverage new technologies in processes.
• Provide interpretation and consultation on regulations, guidelines, compliance status, and policies for project teams.

Additional Responsibilities

• Be the point of contact with sites assessed for inspection readiness.
• Propose updates to Global QMS documents or local SOPs based on identified compliance gaps.
• Assist in training and coaching of guest assessors.
• Promote continuous improvement related to 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 and share learnings from significant regulatory inspections.
• Develop and maintain tools to support the inspection readiness process and ensure actionable metrics are in place.

Qualifications

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

Preferred Qualifications

• Knowledge of global cGMPs and regulatory requirements; experience in regulatory inspections, standards, and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, sterile products.
• Experience identifying regulatory inspection risks.
• Expert knowledge in specific pharmaceutical dose forms, APIs, manufacturing processes, or regulatory submissions.
• Familiarity with primary/secondary manufacturing, biopharmaceuticals, and 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 driving process improvements for inspection readiness.

Education

• Bachelor‚Äôs degree required; advanced degree preferred.