PQV Trending & Monitoring Analyst

Lead, conduct, and support complaint trending, signal detection, and data analysis activities for product quality complaints across global products and manufacturing sites.

Evaluate complaint information from a technical, product, process, and data perspective to ensure appropriate trend analysis, signal evaluation, investigation linkage, and documentation are completed prior to escalation, closure, or governance review.

Act as a PQV point of contact for manufacturing sites and cross-functional business partners on trend insights, signal awareness, aging or coming-due signal assessments, prioritization, data quality, and complaint analysis needs.

Provide guidance, coaching, and support to internal and external business partners on complaint trending expectations, data interpretation, report outputs, and related quality system requirements.

Support regulatory inspections, audits, health authority requests, Complaint Vigilance Review Board discussions, business partner requests and senior management reviews by preparing clear data outputs, analyses, explanations, and recommendations.

Execute transactional tasks to support the complaint management process (data collection/ review, complaint record review, etc).

Lead global, cross functional improvement projects.

• Bachelor’s degree in a technical, scientific, engineering, statistics, microbiology, data analytics, quality, or related discipline is required; equivalent experience may be considered where applicable.
• Minimum of 5+ years of related experience, including experience working in pharmaceutical, consumer, medical device, quality assurance, quality control, complaint management, post-market vigilance, risk management, compliance, or another highly regulated industry.
• Advanced knowledge and proficiency in Microsoft Excel for data analysis and signal detection, including macros, tables, lookups, and related analytical functions.
• Experience with signal detection, complaint trending, product quality monitoring, or data-driven quality surveillance activities is preferred.
• Experience working with large datasets, complaint systems, quality systems, data processes, dashboards, or technical reporting is preferred.
• Working knowledge of complaint handling, quality system regulations, and regulated industry expectations, including applicable GMP, GDP, GVP, medical device, pharmaceutical, and combination product requirements, is preferred.
• Demonstrated ability to communicate effectively verbally and in writing, including technical writing, data storytelling, persuasive communication, and presentations to multiple organizational levels.
• Global mindset with demonstrated ability to lead change initiatives, manage projects, develop strong relationships, influence without authority, and work independently in a cross-functional environment.