What are the responsibilities and job description for the Senior Manager, Small Molecule CMC Compliance & Inspection Readiness position at Katalyst CRO?
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.