Quality Inspection Readiness Manager

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com. 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 Contribute to ongoing maturity/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 presentation, Site Master File, SME list and development of storyboards Support initiatives associated 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 Support inspection forecasting and development/maintenance of tools used to support inspection readiness Small Molecule GMP Evidence to support GMP activities Support incoming requests for Small Molecule 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 Lead and assist with additional projects and provide project management support/oversight as needed Requirements Master’s degree and 3 – 4 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field and 5+ years of relevant work experience, or relevant comparable background 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 Continuous Process Improvement Skills Knowledge and application of GMP regulations and application to Manufacturing and Testing risk management principles Root Cause Analysis tools/methodology and CAPA #J-18808-Ljbffr ELIQUENT Life Sciences