Senior Manager, Product Complaints

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made . We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.   For more information, please visit www.resilience.com The Senior Manager, Product Complaints owns the product complaints program to ensure timely evaluation, investigation, and closure of product quality complaints in compliance with GMP, regulatory, and company requirements. This role ensures that complaint trends are analyzed, escalated when applicable, and used to drive continuous improvement in product quality and patient safety. The role sets goals and priorities for the complaints program, manages the investigation and timelines required across Quality and the Investigation Team, and applies judgment on reportability and product-impact decisions that affect site operations and client commitments. The Senior Manager leads and develops complaint handling staff and influences site leadership, global quality, clients, and auditors on complaint-related risk and remediation decisions.

Core Responsibilities Complaint Intake & Triage: Own the process of receiving, triaging, and categorizing complaints, setting criticality criteria and turnaround expectations, and ensuring consistent application of processes across complaints. Investigation & Analysis: Set investigation standards and approve conclusions on root cause, product impact, reportability, and CAPA initiation; personally lead escalated, precedent-setting, or client-sensitive cases. Compliance: Ensure all complaint handling activities comply with relevant regulations and company procedures. Accountable for the timely and compliant delivery of complaint responsibilities in accordance with Quality Agreement requirements. Trend Reporting: Prepare and present quarterly and annual complaint trend reports to site and global quality leadership, highlighting recurring root causes, emerging risk signals, and recommended actions to drive continuous improvement. Client & Regulatory Communication: Serve as the authoritative voice on complaint findings and outcomes to clients and regulatory agencies, including responses to client quality inquiries and regulatory requests. Process Improvement: Design and implement improvements to complaint handling processes, partnering with other departments to implement solutions. Cross-functional Collaboration: Lead cross-functional teams (e.g., quality assurance, manufacturing, quality control, clients) to resolve complaints and prevent future occurrences. Documentation: Ensure all complaint-related documentation is accurate, complete, and maintained according to regulatory requirements. Review and approve complaint investigations and complaint-related documentation (e.g., forms, SOPs, work instructions). Performance Monitoring: Define complaint handling KPIs and performance targets, set team goals against them, and act on adverse trends. Inspection Readiness Represent the Product Complaints Program as subject-matter expert during internal audits and external inspections by the FDA and other regulatory agencies, including client quality audits, and own responses and commitments arising from complaint-related observations. Own complaint-related inspection readiness, including document availability, back-room support to the Logistics Center or Inspection Room, and preparation of staff called as subject-matter experts. Leadership & Program Ownership Partner with Manufacturing, QC, QA, and client-facing teams to secure the resources and commitments needed to close complaints within required timelines. Set annual improvement goals for the complaints program and deliver them through team-based processes and key performance indicators. Influence and educate