Inspection Readiness Manager in London

12-month contract

Location: Hybrid (3 days on site in Paddington, London or Dublin, Ireland)

Department: Quality Standards Management

Reporting into: Inspection Readiness Associate Director

General position summary: This role is responsible for providing support with real-time inspection readiness activities supporting GMP quality. The role requires the ability to adapt to pipeline program milestones, whilst effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. The role is responsible for providing technical expertise and project management of inspection readiness, as well as providing support during inspections. This role is recognized as an expert in the principles and application of quality assurance and compliance, and the role includes partnering with various internal and external cross-functional teams including Contract Manufacturing Organizations, Technical Operations, Supply Chain and others within Quality Assurance.

Key Responsibilities:

• Real-time Inspection Readiness
• Develop, manage and contribute to ongoing maturity of GMP Inspection Readiness Plans associated with regulatory filings and real-time inspection readiness activities.
• Work directly with CMOs 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.
• Provide PM oversight of readiness activities.
• Build and maintain dashboards.
• Assist with developing and providing oversight of mitigation plans.
• Develop evidence binders for inspections.
• 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 presentation, Site Master File, SME list and development of storyboards.
• Support initiatives associated with maintaining relevant inspection related history for inspection readiness purposes.
• Provide cross-functional support and guidance to stakeholders.
• Provide additional support for CMO inspection readiness plans and support management of CMO inspections and responses.
• GMP Evidence to support GMP activities.
• Support incoming requests for GMP Certificates for vendors and Vertex sites.

Other Activities:

• Identify areas of improvement and participate in process improvement initiatives.
• Additional as needed support to processes, systems, procedures to ensure continuous Quality improvement.
• Additional activities as needed to support the SM CMC Compliance Team.
• Author/Revise Standard Operating Procedures.
• Lead and assist with additional projects and provide project management support/oversight as needed.

Minimum qualifications:

• Master's degree or Bachelor's degree in a scientific or allied health field with relevant comparable background (biologics and medical device preferred).
• Proficient at creating tools and processes for efficient execution.
• Proficient in project management and utilization of PM tools.
• Proficient communication skills to facilitate successful cross-functional collaboration.
• Results driver who operates with a sense of urgency and can navigate a fast-paced environment.
• Organizational skills and ability to work both independently and cross-functionally.
• Critical, Analytical and Strategic thinking - Ability to assess impact across multiple procedures and systems.
• Problem Solving skills.
• Continuous Process Improvement Skills.
• Knowledge and application of GMP regulations and application to manufacturing and testing risk management principles (biologics and medical device preferred).
• Root Cause Analysis tools/methodology and CAPA.