Quality Assurance Manager

Role Overview

The Quality Assurance Manager at Biofusion will oversee and support various clinical operations projects to ensure adherence to protocols, timelines, and regulatory standards. This position requires coordinating with internal teams and external vendors to facilitate successful project delivery and compliance.

Key Responsibilities

• Lead and supervise clinical research and trial projects from inception through completion.
• Develop and implement operational strategies, study protocols, and budgets.
• Manage daily clinical trial operations, including patient recruitment, retention, and data collection.
• Ensure all processes comply with ethical standards, Good Clinical Practice (GCP), and FDA regulations.
• Oversee data management activities to maintain data integrity, accuracy, and regulatory compliance.
• Coordinate communication and collaboration among cross-functional teams and external partners.
• Mentor and guide junior researchers and clinical staff to foster professional growth.

Qualifications and Requirements

• Bachelor’s degree or higher in Health Sciences, Life Sciences, Nursing, Data Science, or related fields; advanced degrees such as a Master's or PhD in clinical research are highly valued.
• Relevant clinical operations or research management experience ranging from 1 to 5+ years depending on role specificity.
• Strong organizational, multitasking, and project management abilities.
• Excellent communication, leadership, and problem-solving skills.
• Proficiency in clinical trial processes, protocol development, and regulatory compliance knowledge (GCP, FDA).
• Experience in data management with competency in statistical and clinical data software is a plus.

Additional Information

This role involves managing multiple aspects of clinical trials including logistics coordination, budget oversight, documentation maintenance, and ensuring ethical conduct throughout study phases. Candidates should be capable of working independently as well as collaboratively within diverse teams. Experience mentoring junior staff and leading projects is beneficial.