Inspection Readiness Manager

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

POSITION SUMMARY

The Inspection Readiness Manager role is responsible for managing real-time inspection readiness activities supporting GMP and GDP quality. The role requires the ability to adapt to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. The role provides technical expertise and project management of inspection readiness, as well as support during inspections. This role partners with various internal and external cross-functional teams including Contract Manufacturing Organizations, internal manufacturing sites, Technical Operations, Supply Chain, and others within Quality Assurance.

KEY RESPONSIBILITIES

Real-Time Inspection Readiness

• Develop, manage, and contribute to ongoing maturity of GMP and GDP Inspection Readiness Plans

• Work directly with CMOs and internal manufacturing sites on inspection readiness activities, including identification of potential inspection risks

• Work with internal teams on key issues to ensure inspection readiness

• Develop project management plans with key metrics and provide PM oversight of readiness activities

• Build and maintain dashboards and contribute to ongoing growth of the inspection readiness program

• Assist with developing and providing oversight of mitigation plans

• Develop evidence binders for inspections

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

• Perform routine quality system checks to support readiness

• Identify and communicate risks

• Utilize tools and project management skills to ensure efficiency in execution

• Assist in maintenance of opening presentations, Site Master Files, SME lists, and storyboards

• Provide inspection support for affiliate inspections including storyboard simulation

• Provide cross-functional support and guidance to stakeholders

• Support CMO inspection readiness plans and management of CMO inspections and responses

• Support inspection forecasting and maintenance of tools used to support inspection readiness

Small Molecule GMP Evidence

• Support incoming requests for Small Molecule GMP/GDP Certificates for vendors and internal manufacturing sites

Additional Activities

• Identify areas of improvement and participate in process improvement initiatives

• Author and revise Standard Operating Procedures

• Lead and assist with additional projects and provide project management support as needed

MINIMUM QUALIFICATIONS

• Master's degree and 3 to 4 years of relevant experience, or Bachelor's degree in a scientific or allied health field and 5 or more years of relevant experience

• Proficient in project management and utilization of PM tools

• Strong communication skills to facilitate cross-functional collaboration

• Results-driven with a sense of urgency in a fast-paced environment

• Strong organizational skills with ability to work independently and cross-functionally

• Critical, analytical, and strategic thinking skills

• Strong problem-solving and continuous process improvement skills

• Knowledge of GMP/GDP regulations, risk management principles, root cause analysis, and CAPA

ADDITIONAL CONTEXT

• Responsible for external vendors, CMOs, and inspection readiness across multiple sites

• Ideal candidates will have strong PM skills and experience engaging with cross-functional and external partners

• Direct inspection management experience is a strong plus

• Candidates with operational quality or CMO oversight experience will also be considered