KEY CAPABILITIES:

• Understanding of SOP/Standards management and methods/technology used to drive knowledge management across a diverse R&D environment
• Communicate effectively
• Develops innovative and creative output based on interpretation and analysis
• In-depth disciplinary knowledge; leverages business acumen and subject matter expertise
• Employs project management techniques
• Thorough understanding of business priorities, strategy and direction
• Integrates trends, data and information into plans, deliverables and recommendations
• Acts as a technical expert in GCP
• Employs critical thinking skills
• Able to separate critical from non-critical issues
• Strong attention to detail and proficiency in managing data and reports.

WHAT YOU WILL DO

Under general supervision, this position will support the Quality Risk Management team activities. The role involves applying Good Clinical Practice knowledge and functional skills to ensure high-quality execution of assigned tasks and initiatives. The associate will manage trackers and tools, contribute to new process implementation efforts, and provide timely, proactive communication and updates to stakeholders.

KEY RESPONSIBILITIES:

• Coordinate assigned project tasks and ensure delivery within scope, time, and quality standards.
• Maintain and update quality risk management tools, and documentation.
• Support deviation, CAPA, and planned deviation management processes.
• Communicate status updates and escalate issues proactively.