Senior Manager, Product Complaints

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 timely and compliant delivery 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.
• Client & Regulatory Communication: Serve as the authoritative voice on complaint findings and outcomes to clients and regulatory agencies.
• Process Improvement: Design and implement improvements to complaint handling processes, partnering with other departments.
• 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 related documentation.
• 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.
• Own complaint-related inspection readiness, including document availability, back-room support, and preparation of staff called as subject-matter experts.

Leadership & Program Ownership

• Partner with Manufacturing, QC, QA, and client-facing teams to secure 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.
• Serve as the site point of contact (SPOC) for the Product Complaints Program with site teams, global teams, clients, and auditors.
• Determine staffing, systems, and budget needs for the complaints program and negotiate timelines and resources with peer functional leaders.

Education & Experience Minimum Requirements

• Expert knowledge of cGMP in the Pharma/Biotech industry, including FDA, EU, and JP regulatory requirements and ICH/ISO guidelines.
• 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 cross-functional partners without direct authority.
• 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.

Preferred Requirements

• 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.