Director, PQV Trending and Insight
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Titusville • New Jersey • Pennsylvania • United States
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Salary
💰 $150,000 - $258,750 per year
Job Level
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.
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.
- Experience with corresponding to inquiries associated with regulatory agencies is desirable.
- Strong knowledge and understanding of regulatory requirements.
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysisdata evaluationcomplaint trending processquality metrics reportingprocess improvementrisk managementaudit readinessregulatory complianceproduct quality investigationbenchmarking data
Soft Skills
leadershipcollaborationcommunicationorganizational skillsproblem-solvinganalytical thinkingteam managementcross-functional teamworktime managementcontinuous improvement
Certifications
Registered NursePhysician AssistantBiomedical Engineeradvanced degree in Pharmaceuticalsadvanced degree in Regulatoryadvanced degree in Qualityadvanced degree in Business