Senior Manager, Post-Market Surveillance

## Description

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.

## Qualifications

• Bachelor’s degree in engineering, Life Sciences, or related field (master’s preferred)
• 8+ years in Quality/Regulatory roles in medical device, pharmaceutical, or combination products
• 3+ years of leadership experience in complaint handling or Post-Market Surveillance
• Excellent communication and leadership skills with the ability to influence senior stakeholders.
• Ability to manage multiple priorities and drive execution in a fast-paced environment.

**Supervisory Responsibilities**

• Expert knowledge of:
• 21CFR 820, 806, 806
• 21 CFR 210/211
• 21 CFR Part 4
• Cross-functional leadership and influence
• Data-driven decision-making and analytical thinking
• Strong organizational and prioritization skills
• Effective communication across all levels of the organization
• Ability to operate in ambiguity and drive structure

**Competencies**

• Lead and develop a team responsible for complaint intake, investigation, and regulatory reporting activities
• Define roles, responsibilities, and performance expectations for complaint handling personnel across both sites
• Conduct hiring, onboarding, training, performance reviews, and succession planning
• Allocate resources across sites to ensure balanced workload and timely complaint processing
• Ensure clear delineation of site responsibilities (e.g., intake vs. investigation vs. reporting) while maintaining a unified process
• Resolve cross-site conflicts and escalations related to ownership, priorities, or decision-making

**Physical Demands and Work Environment**

• Standard Office Environment
• Occasional travel may be required