Director, Pqv Trending and Insight

Job Function:
Quality
Job Sub Function:
Customer/Commercial Quality
Job Category:
People Leader
All Job Posting Locations:
Beerse, Antwerp, Belgium, Schaffhausen, Switzerland

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

North America - Requisition Number: R-054770

Europe - Requisition Number: R-055481

We are searching for the best talent for Director, PQV Trending and Insight to be in New Jersey and Pennsylvania.

The Director, Trending and Insights leads the global process for trending product quality complaint data and generating actionable insights to drive proactive quality improvements across all JJ Innovative Medicine (IM) commercial products. This role provides oversight of complaint trending methodologies, ensures compliance with regulatory standards, and represents JJ IM during health authority inspections. The Director is accountable for delivering strategic insights through data analysis, signal detection, and product performance monitoring, while fostering cross-functional collaboration with PQV, PQM, MSAT, DPDS, Regulatory Affairs, Medical Safety, and Commercial Quality teams. Responsibilities include managing product trends, identifying signals and need for investigations, maintaining risk registers, supporting audit readiness, and driving continuous improvement initiatives.

The Director ensures that complaint vigilance processes align with corporate standards and are executed using

appropriate system tools, ultimately enhancing the complaint management process, product quality, patient safety,

and regulatory compliance.

Key Responsabilities:

• Provides leadership and support in execution of the centralized complaint trending process and associated systems globally. Manages overall product quality complaint trending process including evaluating and coordinating within PQV and with JJIM business partners in the investigation of product quality complaints trends. Evaluates data and prepares routine and ad hoc reports for management and partners. Performs statistical analysis to identify trends/patterns in complaint data. Monitors complaint trending process for continuous improvement. Works with the business partners to ensure appropriate investigations are completed and closed in a timely manner.
• Establishes and maintains processes and procedures to ensure complaint trending is meeting and exceeded for timely processing and investigation of complaints, notification to management, insights, and trending. Maintains a process for system surveillance and timely escalation to management of adverse trends within the product quality complaints data. Manages and oversees processes for system-wide collection and reporting of metrics that demonstrate the acceptable functioning of the quality system and illuminating areas for improvement.
• Focus on efforts to evaluate end to end complaint process insights and proactively drive quality improvements using complaint metrics, process opportunities, and benchmarking data. Collaborate with cross-functional teams to develop and implement effective action plans, manage risk registers, and support audit readiness. Drive robust complaint handling practices, focusing on procedural enhancements, and data to inform strategic decisions and to maintain high standards of quality and compliance. Leverage the Complaint Vigilance Review Board (CVRB) to inform and drive actions related to product and process risk.
• Leads or Participates on PQV and Commercial Quality project teams; supports development, effective implementation, continued maintenance, and ensures compliance is achieved and standards are met. Represents PQV processes to regulatory agencies, and support regulatory inspections. Ensures audit readiness of PQV processes and documentation. Liaison between PQV and Product Quality Management, IM Supply Chain Quality, Commercial Quality, Medical Safety, and other JJ IM organizations to ensure comprehensive, cohesive, and consistent process execution and documentation. This includes creation and maintenance of controlled documentation (e.g., Standards, SOPs, WI, etc.), delivering training/orientation, coordinating changes, etc.
• Manages and provides leadership and organizational capability development and ensures succession planning and performance standards remain at an optimal level to maintain compliance. Incumbent will interact with Sr. Director, Directors, and Vice Presidents in JJ IM. Manages Trending team priorities, assignments, and performance. Perform process and system training as required.

Trending
- Lead strategic initiatives focused on trend analysis, signal detection, and data analytics to identify oppor