Quality Inspection Readiness Director

Role Summary

As a Quality Inspection Readiness Director, you will support sites to meet regulatory standards and maintain inspection readiness on an ongoing basis. 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.
• Prepare clear and objective assessment reports to communicate inspection readiness risks to senior management and ensure appropriate corrective action plans are implemented.
• During Inspection—Provide support for regulatory Inspections (e.g., SME coaching, Control Room and Inspection Room Support).
• Post Inspection—Review regulatory responses as part of the central review team process, perform Global Assessments and participate in After Action Reviews; initiate Multi-Site Commitment actions if required.
• Serve as a business partner to enhance risk management capabilities and actively identify 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 and engagements before the next site inspection to ensure closure of actions.
• Attend internal GMP/GDP forums as a subject-matter expert, providing recommendations for continued compliance and support the adoption of new technology in the current processes.
• Provide interpretation and consultation to project teams on (new/updated) regulations, guidelines, compliance status and policies and procedures.
• Be the point of contact with sites being assessed for inspection readiness.
• Propose updates to Global QMS Documents and/or local site SOPs based upon identified compliance gaps.
• Assist in training and coaching of guest assessors.
• Expand knowledge through proactive knowledge sharing and collaboration.
• Promote excellence and continuous improvement associated with inspection readiness, best practice 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 associated with Inspection Readiness team.
• Participation in IR CoP/Compliance Forum.
• Share learning from significant Regulatory Inspections across GSC as necessary.
• Develop and maintain tools to support inspection readiness process.
• Ensure suitable metrics (KPIs) are in place and are 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; experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, 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.

Education

• Bachelor’s degree in a relevant field or equivalent experience.

Skills

• Regulatory compliance and GMP/GDP expertise
• Experience with regulatory inspections and quality management systems
• Ability to coach and train site SMEs for GMP regulatory inspections
• Strong risk management capabilities and ability to share best practices
• Interpretation and consultation on regulations, guidelines, policies and procedures
• Development of tools and metrics to support inspection readiness and decision-making

Additional Requirements

• Hybrid role requiring proximity to a GSK site
• Travel up to 50%