This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted.

GENERAL POSITION SUMMARY:The Inspection Readiness Manager role is responsible for leading real-time inspection readiness activities supporting Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) quality systems. The position requires adaptability to new and concurrent projects while ensuring alignment with organizational goals and compliance with all applicable regulatory requirements. The role provides technical expertise and project management related to inspection readiness and offers hands-on support during inspections. It requires deep knowledge of quality assurance principles and collaboration across internal and external cross-functional teams, including Contract Manufacturing Organizations (CMOs), manufacturing sites, technical operations, supply chain, and quality assurance functions.

KEY RESPONSIBILITIES:

Real-Time Inspection Readiness

• Develop and manage GMP/GDP Inspection Readiness Plans associated with regulatory filings and inspection readiness activities.

• Partner with CMOs and manufacturing centers on inspection readiness, including risk identification and mitigation planning.

• Coordinate with internal teams to address key issues and ensure readiness.

• Develop and maintain project management plans with clear milestones and performance metrics.

• Build and maintain dashboards and inspection readiness tracking tools.

• Contribute to the development and evolution of the inspection readiness program.

• Prepare evidence binders and documentation to support inspection activities.

• Support global expansion activities as they relate to inspection readiness and regulatory intelligence.

• Perform quality system checks and identify risks related to inspection readiness.

• Maintain key inspection-related documentation such as opening presentations, site master files, SME lists, and storyboards.

• Provide support for mock inspections, inspection simulations, and affiliate inspection activities.

• Assist with forecasting inspections and maintaining tools to support planning and execution.

GMP Evidence Support

• Fulfill requests for GMP/GDP certificates and documentation to support manufacturing and vendor compliance.

Other Responsibilities

• Identify and contribute to areas for continuous process and quality improvement.

• Provide project management support for cross-functional initiatives.

• Author or revise standard operating procedures (SOPs).

• Support compliance and quality system improvement projects and tasks as needed.

MINIMUM QUALIFICATIONS:

• Master’s degree with 3–4 years of relevant experience, or a Bachelor’s degree in a scientific or allied health field with 5+ years of relevant experience.

• Demonstrated proficiency in developing tools and processes for streamlined execution.

• Strong project management skills with experience using project management tools.

• Effective communicator with the ability to lead cross-functional collaboration.

• Strong organizational, critical thinking, and problem-solving skills.

• Capable of working independently and as part of a team in a dynamic environment.

• Experience with:

  • GMP and GDP regulations and their application to manufacturing and testing.

  • Risk management and mitigation principles.

  • Root cause analysis and Corrective and Preventive Actions (CAPA).

  • Continuous process improvement methodologies.