Manager, Product Complaints
Azurity Pharmaceuticals - US•Raleigh, NC
•Hybrid
About The Position
The Manager, Product Complaints at Azurity will play a crucial role in overseeing global end-to-end complaint intake, investigation, and trending to ensure timely, compliant resolution of product quality issues and drive continuous improvement across the product lifecycle to ensure compliance with regulatory requirements and internal quality standards. This role provides strategic direction in alignment with the Quality Management System (QMS).
Requirements
- Technical writing skills.
- Adaptability / flexibility and ability to work in a fast-paced environment and act with urgency.
- Strong analytical thinking skills, with the ability to translate data into risk-informed insights that drive decision-making.
- Continuous-improvement mindset and strong stakeholder-management capability.
- Knowledge of pharmaceutical product lifecycle management and quality processes.
- Detail-oriented with strong organizational skills, capable of managing multiple tasks.
- Experience with Veeva systems and proficiency in Excel.
Nice To Haves
- Minimum of 8-10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industries
- BS, MSc, or PhD in a scientific discipline.
- Proven experience in inspections/audits.
Responsibilities
- Manage and approve Product Complaints throughout the entire product lifecycle, ensuring timely investigation and resolution.
- Support Field Alerts and Defect Notifications to Health Authorities globally (US, CAN, EU).
- Identify new capabilities, implementing/ delivering improvements.
- Maintain and support inspection readiness.
- Lead product complaint investigations, coordinating with CMOs for external investigations, performing Root Cause Analysis, identifying Corrective Actions, and escalating critical issues to senior management.
- Support SOP management.
- Event/Quality Issue Management process and requirements, including CAPA and Effectiveness Check.
- Project Management, Planning and Prioritization of Product Complaints.
- Support and coordinate complaint trends, KPIs, and quality metrics to identify risks and drive continuous improvement initiatives.
- Prepare management reports, dashboards, and quality trend presentations for senior leadership.
- Collaborate cross-functionally with Quality Operations, Regulatory Affairs, Pharmacovigilance, Supply Chain, and Commercial teams to ensure effective complaint handling and risk mitigation.
- Manage and prepare Risk Assessments for product complaints using both qualitative and quantitative approaches.
Benefits
- Competitive compensation package
- Annual bonus based on company performance
- Incentive compensation program (Sales Only)
- Car reimbursement program (Sales Only)
- Gas card (Sales Only)
- Medical, dental, vision, and prescription coverage
- Hybrid work model
- Retirement Savings Plan (401K) with company match up to 5%
- Up to 15 vacation days annually + rollover
- Five sick/wellness days
- Company closure between Christmas and New Year's
- 13 holidays recognized
- Tuition reimbursement for undergraduate and graduate level courses or certifications
- Azurity High Five peer recognition platform
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Manager
