OneTrust

Director, PQV Trending and Insight

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Beerse • Belgium

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Job Level

Lead

About the role

  • 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 opportunities for product and process improvements across global JJ IM products.
  • Partner cross-functionally to translate data into product insights that drive risk reduction and patient centric solutions, leveraging analytical tools to generate insights that drive proactive quality enhancements and support continuous improvement of the JJIM products.
  • Responsible for collaborating with PQV Product Oriented Delivery (POD) teams to generate actionable insights for business partners (regional CQ) and senior leadership, leveraging product quality data to support decision-making, participate in new product launch CQ governance, and continuous improvement.
  • Lead transforming end to end complaint process insights into proactive quality improvements by monitoring complaint metrics, process opportunities, and ensuring compliance with regulatory standards.
  • Drive cross-functional collaboration to develop and implement effective action plans, manage risk registers, and support audit readiness.
  • This role ensures robust complaint handling practices, facilitates SOP enhancements, and leverages data to inform strategic decisions and maintain high standards of quality and compliance.
  • Analyze and present product quality complaint and compliance issues to senior management within JJ IM. Will interact with Directors, VPs, across all areas, as well as internal audit organizations. Expected to interact with external regulatory bodies.
  • Responsible for leading a team that will use analytics for improving the JJ IM patient experience and driving efficiency/reliability of the complaints process and data. Serve as a talent accelerator who will acquire, cultivate, and develop best in class analytics talent ensuring coaching and development.
  • The Director must have the ability to set the vision, inspire action, partner in achieving alignment, earn the respect of others, and drive cultural change be based on well-developed skills, knowledge, and experience (as identified in the overarching leader and technical capabilities). They must possess the maturity and competency to lead direct reports with proven performance records and mentor/coach/train those outside their direct influence in understanding and adhering to regulations. It should be expected that their leadership influence (implementing the vision and governance) must be extended across the JJ IM to ensure trends meet quality and compliance expectations.
  • Participates directly or indirectly on regional and global complaint vigilance initiatives, and project teams to develop, consolidate, and/or improve complaint vigilance trending, product and process insights with related/interfacing processes.

Requirements

  • Bachelor’s degree or equivalent in technical, life sciences, or engineering field is required.
  • A Registered Nurse, Physician Assistant, Biomedical Engineer or other related license/certification/degree, or advanced degree in Pharmaceuticals, Regulatory, Quality, Business, etc., is helpful.
  • A minimum of 10 years of professional experience in pharmaceuticals, medical device, diagnostics, or related field is required.
  • A proven experience of a team responsible for handling product quality complaints, or related-similar activities, is required.
  • Direct experience with FDA and/or other regulatory audits/inspections is required.
  • Strong knowledge and understanding of regulatory requirements listed below is highly preferred.
  • Experience/knowledge of most regulations relative to post market surveillance activities and reporting, such as: ISO 9001/13485/14971, FDA Regulations (21 CFR (parts 4, 11, 210, 211, 600, 601, 606, 610, 803, 806, 820 etc.)), ICH Q8, 9 & 10, CMDR, JPAL, and Medical Devices Directive (93/42/eec, 98/79/EC)) is helpful.
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
statistical analysisdata analyticstrend analysissignal detectioncomplaint handlingprocess improvementquality complianceaudit readinessregulatory inspectionscontrolled documentation
Soft Skills
leadershipcollaborationcommunicationorganizational capability developmentmentoringcoachinginspiring actioncultural changestrategic decision-makingcross-functional teamwork
Certifications
Registered NursePhysician AssistantBiomedical Engineeradvanced degree in PharmaceuticalsRegulatoryQualityBusiness