Senior Manager, Molecule CMC Compliance & Inspection Readiness

Responsibilities:

• Real-time Inspection Readiness.
• Develop, manage and contribute to ongoing maturity of GMP and GDP Inspection Readiness Plans associated with regulatory filings and real-time inspection readiness activities.
• Work directly with CMOs and the Company Manufacturing Center 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 inspection support for affiliate inspections including storyboard simulation.
• 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/GDP activities.
• Support incoming requests for Small Molecule GMP/GDP Certificates for vendors and Company sites.

• 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.
• Problem Solving skills.
• Continuous Process Improvement Skills.
• GMP/GDP regulations and application to Manufacturing and Testing risk management principles.
• Root Cause Analysis tools/methodology and CAPA.

• 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.