Clinical Project Quality Manager

Role Summary

Clinical Project Quality Manager. Location: Morristown, NJ.

Responsibilities

• Contributes to the development of key study documents (e.g. Protocol, Informed Consent Form, Study Risk Management Plan) to enable quality by design approaches
• Represents Quality on project/study team meetings, providing quality and continuous improvement support
• Proactively monitors progress status of assigned projects
• Provides advice on GCP and Quality issues
• Master thoughtful risk-taking methods to identify and analyze risks and opportunities with potential impact on study quality
• Leverage extensive set of quality metrics to secure control
• Implements in-process quality checks and utilizes performance metrics to inform decisions and prioritize actions to secure inspection readiness throughout study duration
• Drives Pre-Approval Inspection preparation activities
• Assesses and confirms escalated critical deviations, evaluates needs for regulatory reporting
• Applies data analytics to identify quality trends and patterns and recommends corrective and preventive actions based on quality data analysis
• Analyzes signals/events to profile quality risks and propose mitigation strategies
• Manages quality alerts for assigned studies/projects
• Handles cases of Scientific Misconduct and Serious GCP Non-Compliance at study level or program level
• Contributes to the development of clinical audits plan for assigned programs through the identification of risks to Auditing team
• Analyses of audit results, monitors audit findings and ensures effectiveness of CAPAs implemented
• Conducts project/study level trend analysis of deviations or audit findings
• Implement data driven approach to enable study team to focus on issues that matter to quality
• Contributes to continuous quality improvement initiatives
• Promotes a culture of early issue detection & timely resolution
• Provides mentoring and training to newcomers

Qualifications

• Education: Bachelor degree in life/medical/natural sciences or scientific discipline
• Experience: 5+ years experience in the pharmaceutical industry, with experience in GCP clinical and/or GCP quality operations-related roles
• Experience with quality management systems and tools
• Languages: Competent in English (both written and verbal)
• Technical Skills: Working knowledge of international regulations/Guidelines/Good Practices in the clinical domain; Basic proficiency in data analytics tools (e.g., Excel, Power BI); Ability to interpret quality data and metrics; Good working knowledge of standard computer office software; Understanding of digital quality management systems
• Soft Skills: Quality focused with a high degree of personal accountability; Analytical thinking and problem-solving abilities; Ability to analyze situations and provide guidance using a risk-based approach; Project management skills and ability to influence without direct authority; Excellent communication and interpersonal skills; Ability to multi-task and prioritize assignments; Self-motivated with ability to work independently

Skills

• GCP and Quality operations knowledge
• Data analytics and quality metrics interpretation
• Risk-based decision making and CAPA management
• Quality improvement methodologies
• Communication and cross-functional collaboration