Quality Inspection Readiness Director

Role Summary

Role to ensure regulatory compliance and inspection readiness across a global organization. You will assist sites to be inspection ready on a daily basis through coaching, training, and education for sites inspected by regulators (FDA, MHRA, EMA outside Europe, HPRA and China). 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 (FDA, MHRA, EMA outside Europe, HPRA and China) 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
• Preparation of clear and objective assessment reports that ensure senior management is communicated any inspection readiness risks and that appropriate corrective action plans are implemented which are associated with those risks
• During Inspection – Provide appropriate support for all key Regulatory Inspections (e.g. SME coaching, Control Room and Inspection Room Support)
• Post Inspection – Review the regulatory response as part of the central review team process, perform Global Assessments and participate in After Action Reviews. If necessary, initiate Multi-Site Commitment actions if there is a wider GSK impact by the regulatory response
• Serve as a business partner to enhance GSK’s risk management capabilities and actively identify and share good practices and improvement opportunities in the appropriate format
• 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 by a key regulator to ensure they have been closed out effectively
• Attend internal forums (as required) as GMP/GDP expert, providing recommendations to provide recommendations for continued compliance with regulations, in support of the simplification and advancement of the use 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

In addition:

• 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 & 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 (KPI’s) 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 world-wide 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 based 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

Skills

• GMP/cGMP regulatory compliance
• Regulatory inspections experience (FDA, MHRA, EMA, HPRA, China)
• Risk management and CAPA assessment
• Training and coaching of site SMEs and guests
• Interpretation and consultation on regulations, guidelines, policies, and procedures
• Cross-functional collaboration and stakeholder management
• QMS/document control and local SOPs
• Data-driven decision making with KPIs

Education

• Bachelor's degree

Additional Requirements

• Hybrid role; candidate should be close to a GSK site
• Travel up to 50% (global/regulatory inspections)