Group Manager-Inspection readiness

Responsibilities

• Manage the Site Quality Review program and identify key performance indicators to measure site objectives
• Develop strategies for improved compliance and maintain systems to measure performance against established targets
• Oversee the CAPA lifecycle to ensure timely closure and provide periodic metric feedback to management
• Liaise with digital and global teams for the deployment and enhancement of gQTS/eQMS systems
• Act as a Subject Matter Expert for eQMS, managing end users and resolving day-to-day system queries
• Ensure compliance and on-time implementation of corrective and preventive actions derived from regulatory inspections
• Perform regulatory observation gap assessments to identify site gaps and implement CAPAs within agreed timelines
• Coordinate with global Inspection Readiness teams and oversee the inspection readiness tracker
• Design and execute awareness training, campaigns, and GEMBA walkthroughs to prepare staff for audits
• Manage inspection logistics, including the preparation and management of front room and back room operations
• Drive the Quality Culture Maturity Assessment and update the Quality Improvement Plan

Requirements

• Minimum 10 years of experience in the pharmaceutical industry
• Proven experience in managing and handling regulatory agency inspections
• Strong knowledge of GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices)
• Extensive experience in people management, including delegating tasks and setting clear objectives
• Proficiency in technical writing for creating accurate and concise documentation
• Strong problem-solving skills with the ability to identify root causes and implement preventative measures

Preferred Qualifications

• Experience in sterile formulations
• Master’s degree in Sciences or Pharmaceutical Sciences

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to discovering and developing innovative therapies to improve healthcare and transform millions of lives worldwide.