Senior Manager, Post-Market Surveillance

The Senior Manager, Post-market Surveillance is responsible for the strategic leadership, governance, and continuous improvement of the Post-market Surveillance system for Vero Biotech’s combination product portfolio. This role has end-to-end ownership of the complaint handling process, including intake, triage, investigation, and regulatory reporting, across a two-site operating model.

The position ensures compliance with applicable FDA regulations (21 CFR Parts 4, 803, 820, and 210/211 as applicable) and international standards, while driving consistency, inspection readiness, and risk-based decision-making across both sites.

• Complaint Handling System Ownership (Multi-Site)
  • Own and oversee the end-to-end complaint lifecycle across both manufacturing/operational sites, ensuring consistent execution and harmonization.
  • Define and maintain a single global complaint process with clearly delineated site responsibilities, including:
  • Intake and logging
  • Triage and reportability assessment
  • Investigation ownership and execution
  • Closure and trending
  • Establish and maintain a site ownership model (e.g., product ownership vs. investigation ownership vs. reporting accountability).
  • Ensure appropriate escalation pathways for cross-site complaints and systemic issues.
• Combination Product Compliance
  • Ensure complaint handling meets requirements for both device and drug constituent parts, including:
  • Device complaint requirements (21 CFR 820.198)
  • MDR reporting (21 CFR 803)
  • Field alert reporting/drug product considerations, as applicable
  • Lead development and maintenance of combination product complaint decision trees and reportability algorithms.
  • Ensure integration of pharmacovigilance, device vigilance, and quality systems into a unified surveillance process.
• Regulatory Reporting & Vigilance
  • Oversee timely, accurate, and compliant submission of:
    • • Medical Device Reports (MDRs)
      • Corrections and removals (21 CFR 806)
      • Other applicable global vigilance reports
      • Serve as the SME for reportability determinations, ensuring defensible, well-documented decisions.
• Investigation Oversight and Quality
  • Ensure investigations are:
    • • Scientifically sound
      • Risk-based
      • Root-cause driven
      • Completed within established timelines
      • Define requirements for cross-site investigations, including when joint investigations are required.
      • Ensure alignment with CAPA, nonconformance, and signal detection processes.
• Inspection Readiness
  • Ensure the complaint handling system is inspection-ready at all times, including:
    • • Complete documentation
      • Traceability from complaint → investigation → CAPA → closure
      • Clear rationale for reportability decisions
      • Lead preparation and defense of complaint data during FDA inspections and internal audits.