Senior Manager, Product Complaints

Resilience•West Chester, OH

6d•Onsite

About The Position

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. 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.

Requirements

Expert knowledge of cGMP in the Pharma/Biotech industry, including FDA, EU, and JP regulatory requirements and ICH/ISO guidelines, with the ability to interpret and apply them to novel or contested complaint scenarios where internal precedent does not exist.
Demonstrated ownership of a complaint, deviation, or investigation program, including accountability for program-level metrics, regulatory commitments, and Quality Agreement obligations.
Knowledge of pharmaceutical and biotechnology processes: sterile product manufacturing processes, inspection, packaging, labeling, testing, etc.
Demonstrated ability to resolve investigations where root cause is contested or data is incomplete, and to defend conclusions to regulators, clients, and senior leadership.
Demonstrated ability to set direction for a team and for cross-functional partners without direct authority, and to prioritize competing workstreams across sites.
People leadership experience, including hiring, goal setting, performance management, and development of technical staff; strong project management and technical writing skills.
Ability to change the thinking of others in sensitive or escalated situations, including client, regulatory, and senior leadership audiences.

Nice To Haves

Bachelor’s degree in a science/technical field such as pharmacy, biology, chemistry, or engineering.
Advanced degree or MBA.
10+ years of experience in Quality Assurance / Regulatory Compliance within pharma/biotech, including ownership of a complaint, deviation, or investigation program and experience leading people or cross-functional project teams.
ASQ certifications (e.g., CQA, CQE, and CQM).
Active member of pharmaceutical trade associations such as ISPE, PDA, etc.
Experience in a multi-site or global quality organization, including leading complaint or investigation workstreams across more than one site.

Responsibilities

Own the process of receiving, triaging, and categorizing complaints, setting criticality criteria and turnaround expectations, and ensuring consistent application of processes across complaints.
Set investigation standards and approve conclusions on root cause, product impact, reportability, and CAPA initiation; personally lead escalated, precedent-setting, or client-sensitive cases.
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.
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.
Serve as the authoritative voice on complaint findings and outcomes to clients and regulatory agencies, including responses to client quality inquiries and regulatory requests.
Design and implement improvements to complaint handling processes, partnering with other departments to implement solutions.
Lead cross-functional teams (e.g., quality assurance, manufacturing, quality control, clients) to resolve complaints and prevent future occurrences.
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).
Define complaint handling KPIs and performance targets, set team goals against them, and act on adverse trends.
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.
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 operational and support areas on quality and compliance policy, standards, and expectations.
Lead, coach, and develop direct reports, including goal setting, periodic performance reviews, feedback, and recognition; ensure staff are trained and qualified on complaint handling procedures and best practices.
Serve as the site point of contact (SPOC) for the Product Complaints Program with site teams, global teams, clients, and auditors.
Escalate site-specific complaint issues to leadership and clients on a timely basis, including recommended containment and corrective actions.
Determine staffing, systems, and budget needs for the complaints program, set annual workstream priorities for the team, and negotiate timelines and resources with peer functional leaders.