Inspection Readiness Manager / Small Molecule CMC Compliance

Planet Pharma; United States; On-site; USD 125,000 - 178,000; Full time

Job summary

A leading company is seeking an Inspection Readiness Manager to oversee inspection readiness activities for Small Molecule CMC Compliance. The role involves developing plans, coordinating with teams, and ensuring compliance with GMP/GDP regulations. Ideal candidates will have a scientific background and project management skills, with a focus on efficiency and collaboration.

Qualifications

• Master’s degree with 3-4 years or Bachelor’s with 5+ years of relevant experience.
• Proficient in creating tools and processes for efficiency.

Responsibilities

• Ensure successful execution of inspection readiness activities.
• Develop and manage GMP and GDP Inspection Readiness Plans.
• Coordinate with internal teams on key issues to maintain inspection readiness.

Skills

Project Management

Communication

Analytical Thinking

Organizational Skills

Education

Master’s Degree

Bachelor’s Degree in a Scientific Field

Tools

Project Management Tools

Job description

Inspection Readiness Manager / Small Molecule CMC Compliance

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This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $85.00/hr

Key Responsibilities:

• Ensure successful execution of inspection readiness activities, including:
• Develop, manage, and contribute to GMP and GDP Inspection Readiness Plans linked to regulatory filings and real-time inspection activities
• Collaborate with CMOs and Manufacturing Centers on inspection readiness, identifying potential risks
• Coordinate with internal teams on key issues to maintain inspection readiness
• Create and manage project management plans with key metrics
• Oversee readiness activities from a project management perspective
• Build and maintain dashboards for tracking progress
• Enhance the maturity of the inspection readiness program
• Develop and oversee mitigation plans
• Prepare evidence binders for inspections
• Support global expansion activities related to inspection readiness and regulatory intelligence
• Conduct routine Quality System checks to support readiness
• Identify and communicate inspection risks
• Utilize project management tools to ensure efficient execution
• Assist in maintaining inspection-related documentation like the opening presentation, Site Master File, SME list, and storyboards
• Support initiatives to maintain inspection history records
• Provide inspection support, including storyboard simulations for affiliate inspections
• Offer cross-functional guidance to stakeholders
• Support CMO inspection readiness plans and manage inspections and responses
• Develop tools for inspection forecasting and maintenance
• Manage GMP evidence for Small Molecule GMP/GDP activities
• Handle requests for GMP/GDP Certificates for vendors and client sites
• Participate in process improvement initiatives and support continuous Quality improvements
• Lead and support additional projects as needed, providing project management oversight

Qualifications:

• Master’s degree with 3-4 years of relevant experience, or Bachelor’s degree in a scientific or health-related field with 5+ years of relevant experience, or equivalent background
• Proficient in creating tools and processes for efficiency
• Skilled in project management and using PM tools
• Excellent communication skills for cross-functional collaboration
• Results-oriented with a sense of urgency in a fast-paced environment
• Strong organizational skills and ability to work independently and cross-functionally
• Critical, analytical, and strategic thinking skills
• Knowledge of GMP/GDP regulations, risk management, Root Cause Analysis, and CAPA

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Science

Industries

• Staffing and Recruiting