Inspection Readiness Manager - Small Molecule CMC Compliance

Overview

Hybrid
Depends on Experience
Contract - W2
Contract - 6 Month(s)

Skills

Inspection Readiness
Technical Support
Project Management

Job Details

Position: Inspection Readiness Manager - Small Molecule CMC Compliance
Location: Boston, MA - Hybrid (Onsite 3 days/week)
Job Type: Contract
Duration: 6 months to start

Job Description
This role is responsible for managing real time inspection readiness activities supporting GMP and GDP quality. The role requires the ability adapt to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. The role is responsible to provide technical expertise and project management of inspection readiness, as well as provide 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, Manufacturing Center, Technical Operations, Supply Chain and others within Quality Assurance.

This position reports to the Associate Director, CMC Small Molecule Compliance

KEY RESPONSIBILITIES:
The position is responsible to ensure the successful execution, but is not limited to the following:

  • 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 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 client 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 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
  • Knowledge and application of:
  • GMP/GDP regulations and application to Manufacturing and Testing risk management principles
  • Root Cause Analysis tools/methodology and CAPA
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.