What are the responsibilities and job description for the Remediation Program Lead position at Redbock - an NES Fircroft company?
Overview
Our biotech client is seeking a senior-level consultant to lead and support a complex remediation initiative tied to agency observations/warning letter activities across CMO operations. This individual must combine strong project management capabilities with hands-on remediation expertise and executive-level communication skills.
The consultant will work cross-functionally with internal leadership, external CMOs, and quality/manufacturing stakeholders to drive remediation execution and inspection readiness efforts ahead of key regulatory timelines.
Key Responsibilities
- Lead and manage remediation activities associated with agency observations and/or warning letter commitments
- Build and manage integrated remediation project plans, timelines, and execution tracking
- Facilitate cross-functional meetings and drive accountability across internal teams and external CMOs
- Develop executive-level communications, dashboards, and one-page status summaries for leadership updates
- Review remediation plans, CAPAs, and supporting documentation for adequacy, practicality, and regulatory alignment
- Partner directly with CMOs to assess execution strategies and ensure remediation activities are progressing appropriately
- Provide strategic guidance on inspection readiness across manufacturing and testing sites
- Support commercialization readiness initiatives where applicable
- Help drive alignment across multiple stakeholders and functions
Required Background/Experience
- BS degree minimum
- 5 years of medical device industry experience
- Direct experience leading or supporting FDA/agency remediation programs and warning letter remediation activities
- Strong project management experience within regulated life sciences environments
- Demonstrated ability to operate in highly visible, cross-functional environments with senior leadership exposure
- Experience interacting directly with CMOs and external manufacturing partners
- Ability to critically evaluate remediation strategies and determine execution feasibility
- Experience driving remediation execution beyond simple gap assessments or CAPA authorship
- Strong executive presence and communication skills
Preferred Experience
- Combination product experience strongly preferred
- Prior inspection readiness experience highly desired
- Experience supporting global manufacturing networks and external testing labs preferred
- Local to New Jersey preferred, though not required
Engagement Details
- Start: June 2026
- Duration: Through mid-to-late September 2026
- Hours: The client anticipates full-time, ~40 hours/week
- Location: Remote is acceptable, although local to NJ office is preferred
Travel:
- Travel to New Jersey office
- Potential travel to CMO site in France
- International travel helpful but not mandatory
- Additional remediation/CAPA support may extend to other CMO sites and testing laboratories