FSP - Assistant Clinical Quality Control Manager

Role Summary

Fortrea's FSP team is hiring an Assistant Clinical Quality Control Manager home based in the US. Strong candidates fluent in Japanese or other languages are sought. Responsible for the tracking, processing, and reporting to functional stakeholders of Quality Control data, as assigned by a Manager Quality Control or above. Collaborates with Managers, Senior Managers, Associate Directors, and Directors Quality Control to coordinate QC activities, develop and maintain QC tracking systems, and support the Global Quality Control team administration.

Responsibilities

• As assigned, support the development of the functional/regional quality plan outlining processes, metrics, roles, and responsibilities.
• Support the development of functional processes to evaluate and identify performance trends for process improvement; maintain a Quality Dashboard for reporting to functional managers and leadership.
• Under guidance by the LM, identify important trends and best practices in quality management to implement globally; communicate these trends and practices throughout the organization.
• Deliver training to functional stakeholders on quality control processes as assigned.
• Monitor compliance with quality control processes and develop plans to close compliance gaps.
• Monitor quality results against KQI targets; support communication to senior management when performance is unacceptable and assist in implementing corrective action plans for KQIs.
• Deliver training related to quality control tools as required.
• All other duties as needed or assigned.

Qualifications

• Required: University/college degree (life science preferred), or certification in a related allied health profession; in lieu of the above, 3–5 years of relevant experience in pharmaceutical or CRO industries; Fortrea may consider equivalent experience.
• Experience (Minimum Required): Basic understanding of clinical research terminology and ICH-GCP; ability to interact with employees globally; excellent organizational and time management skills; good written and spoken communication; strong computer literacy with Excel and ability to generate presentation slides.
• Preferred: 1+ years of experience in a related field (medical, clinical, pharmaceutical, laboratory, research, data analysis, data management, technical writing, or business development).

Education

• University/college degree (life science preferred), or certification in a related allied health profession (e.g., nursing certification, medical or laboratory technology); in lieu of the above, 3–5 years of relevant experience in pharmaceutical or CRO industries may be considered.

Additional Requirements

• Physical Demands/Work Environment: Office environment with exposure to electrical equipment; travel to client sites domestic and international; travel requirements around 15%; ability to sit for extended periods; occasional lifting up to 15–20 lbs; varied hours may be required.