Quality Inspection Readiness Director

Role Summary

As a Quality Inspection Readiness Director, you will ensure sites remain inspection ready and compliant with regulatory standards across multiple regulators (FDA, MHRA, EMA outside Europe, HPRA, and China). You will coach, train, and educate site teams, provide expert guidance, and drive continuous improvement in GMP and regulatory processes. You will collaborate with cross-functional teams to apply regulatory knowledge to the introduction of new technologies while supporting regulatory compliance objectives.

Responsibilities

• Support GSK sites and related functions to be inspection ready through pre-, during-, and post-inspection activities (including PAI inspection readiness) for regulators such as FDA, MHRA, EMA outside Europe, HPRA, and China.
• Pre-Inspection: prepare for, conduct, and manage inspection readiness assessments of sites using a risk-based approach.
• Prepare clear, objective assessment reports communicating inspection readiness risks to senior management and outlining effective corrective action plans.
• During inspections: provide support for regulatory inspections (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 required.
• Serve as a business partner to strengthen GSK's risk management capabilities and actively 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 CAPAs for regulatory inspections and engagements to ensure closure before the next site inspection.
• Attend internal GMP/GDP forums as an expert, providing recommendations to maintain compliance and support the adoption of new technologies in current processes.
• Provide interpretation and consultation to project teams on new or updated regulations, guidelines, compliance status, and policies and procedures.
• Be the primary point of contact with sites being assessed for inspection readiness.
• Propose updates to Global QMS documents and/or local site SOPs based on identified compliance gaps.
• Assist in training and coaching of guest assessors.
• Expand knowledge through proactive knowledge sharing and collaboration.
• Promote excellence and continuous improvement in inspection readiness, best practices, and processes.
• Support site capability building through training and coaching of site SMEs in preparation for inspections.
• Work with the QMS team on QMS policies and global processes related to the Inspection Readiness team.
• Participate in IR CoP/Compliance Forum.
• Share learnings from significant regulatory inspections across GSC as necessary.
• Develop and maintain tools to support the inspection readiness process.
• Ensure KPIs are defined and available to support decision-making within GSK.

Qualifications

• Required: Bachelor's degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
• Preferred: Good knowledge of worldwide cGMPs and regulatory requirements; and experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, and sterile.
• Preferred: Proficiency and experience in identifying Regulatory Inspection Risks.
• Preferred: Demonstrated expert knowledge and experience in one or more specific pharmaceutical dose forms or technologies, APIs, manufacturing processes and regulatory submissions.
• Preferred: Broad familiarity with Primary, Secondary manufacturing and Biopharmaceuticals, sterile manufacturing.
• Preferred: Good knowledge of the pharmaceutical industry current best practice in analytical and manufacturing technologies, engineering practices, validation and GMP compliance.
• Preferred: Knowledge of risk management principles and application.
• Preferred: Understanding and experience of corporate governance processes.
• Preferred: Serious incident management with demonstrated ability to resolve quality issues.
• Preferred: Demonstrated improvement in processes associated with being inspection ready.

Additional Requirements

• Hybrid role; must be based near a GSK site. Travel up to 50%.