Schedule:
- Initial phase: 3–4 days per week
- Ongoing: ~2 days per week, based on quality needs
Overview
A pharmaceutical organization that recently launched a long-acting injectable (LAI) product is seeking an experienced FDA Inspection Readiness & Quality Consultant. This individual will play a critical role in preparing for and leading FDA inspections, strengthening local quality systems, and serving as the on-site inspection lead when the FDA is present.
This is a hands-on, on-site consulting role requiring extensive FDA inspection experience, particularly with outside FDA inspections, and the ability to build and mature quality systems in a growing organization.
Key Responsibilities
- Lead FDA inspection readiness activities following the launch of a new drug product
- Serve as the primary on-site lead during FDA inspections, including direct interaction with inspectors
- Assess, build, and strengthen the local quality system to ensure inspection readiness and compliance
- Identify gaps, risks, and remediation plans related to FDA expectations
- Prepare teams, documentation, and processes for FDA review
- Guide internal stakeholders on inspection best practices and inspection conduct
- Support ongoing quality needs as the organization matures post-launch
Required Qualifications (Most Important)
- Extensive hands-on experience leading FDA inspections, including outside FDA inspections
- Strong background in FDA inspection preparedness and execution
- Experience supporting or inspecting long-acting injectable (LAI) products strongly preferred
- Deep knowledge of FDA regulations, quality systems, and compliance requirements
- Proven ability to lead inspections calmly, confidently, and professionally
Additional Requirements
- Must be commutable to the Princeton, NJ office
- Ability to be fully on-site during FDA inspections
- Comfortable working in a part-time, consulting capacity
- Able to operate independently and provide strategic and hands-on support