FSP - Assistant Clinical Quality Control Manager

Fortrea • Durham, CA

12d • $135 - $148 • Remote

About The Position

Fortrea's FSP team is hiring an Assistant Clinical Quality Control Manager home based in the US. Seeking strong candidates that are fluent in Japanese or other languages. Job Overview: Responsible for the tracking, processing, and reporting to functional stakeholders of Quality Control data, as assigned by a Manager Quality Control or above. Success in this role will require close collaboration with the Managers, Senior Managers, Associate Directors, and Directors Quality Control who may assign specific QC activities to the Assistant Manager Quality Control. Responsible for development and/or maintenance of tracking systems for Quality Control (QC) activities. Coordination of administrative matters concerning the Global Quality Control team. Assist in QC activities, including coordination and follow up on CQC visits. Assist in the maintenance of measurement systems to assess the performance of our quality management process against Key Quality Indicators. Maintain pre-defined metrics including the maintenance of a Quality Dashboard, to support the Quality Control team in reporting the quality status to functions, as assigned. Assist in the processing, analyzing and visualization of data related to QC activities to support the communication of quality control results. Assist in the implementation of quality planning, monitor, and control processes and tools to ensure quality of the deliverables in the assigned function(s) can improvement in assigned quality control processes. The scope of the processes will include operational (function specific) and global processes and may extend to such as management of SOPs and training. The Assistant Quality Control Manager will not be responsible for executing established quality processes since this will be the responsibility of Project Leaders and functional leaders, respectively. Summary of Responsibilities: As assigned, support the development of the functional/regional quality plan outlining processes, metrics, roles, and responsibilities. Support the development of functional processes that will be used to evaluate and identify performance trends that indicate the need for process improvement. This will include maintenance of a Quality Dashboard for reporting purposes to functional managers and leadership. Under guidance by the LM, identify important trends and best practices in quality management in the organization that need to be implemented globally. Develop effective ways to communicate these trends and practices throughout the organization to ensure maximum benefit is realized. As assigned, deliver training to functional stakeholders on quality control processes. As assigned, monitor compliance with quality control processes and develop plans to close compliance gaps. As assigned, monitor quality results against our KQI targets to ensure performance is acceptable. If performance is unacceptable or when significant unresolved quality concerns exist, support communication to senior management. As assigned, support the implementation of corrective action plans when performance gaps exist for KQIs. As assigned, deliver training related to quality control tools as required. All other duties as needed or assigned.

Requirements

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• In lieu of the above requirement, candidates with one (3-5) or more years of relevant experience in pharmaceutical or CRO industries will be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Basic understanding of clinical research terminology and ICH-GCP.
• Ability to interact and engage employees across the globe.
• Excellent organizational and time management skills.
• Good communication skills, oral, and written.
• Good computer literacy.
• Knowledge of Excel and the ability to generate presentation slides is essential.

Nice To Haves

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• In lieu of the above requirement, candidates with one (3-5) or more years of relevant experience in pharmaceutical or CRO industries will be considered.
• One (1) or more years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management, technical writing, or business development)

Responsibilities

• Responsible for the tracking, processing, and reporting to functional stakeholders of Quality Control data, as assigned by a Manager Quality Control or above.
• Responsible for development and/or maintenance of tracking systems for Quality Control (QC) activities.
• Coordination of administrative matters concerning the Global Quality Control team.
• Assist in QC activities, including coordination and follow up on CQC visits.
• Assist in the maintenance of measurement systems to assess the performance of our quality management process against Key Quality Indicators.
• Maintain pre-defined metrics including the maintenance of a Quality Dashboard, to support the Quality Control team in reporting the quality status to functions, as assigned.
• Assist in the processing, analyzing and visualization of data related to QC activities to support the communication of quality control results.
• Assist in the implementation of quality planning, monitor, and control processes and tools to ensure quality of the deliverables in the assigned function(s) can improvement in assigned quality control processes.
• As assigned, support the development of the functional/regional quality plan outlining processes, metrics, roles, and responsibilities.
• Support the development of functional processes that will be used to evaluate and identify performance trends that indicate the need for process improvement.
• Under guidance by the LM, identify important trends and best practices in quality management in the organization that need to be implemented globally.
• Develop effective ways to communicate these trends and practices throughout the organization to ensure maximum benefit is realized.
• As assigned, deliver training to functional stakeholders on quality control processes.
• As assigned, monitor compliance with quality control processes and develop plans to close compliance gaps.
• As assigned, monitor quality results against our KQI targets to ensure performance is acceptable.
• If performance is unacceptable or when significant unresolved quality concerns exist, support communication to senior management.
• As assigned, support the implementation of corrective action plans when performance gaps exist for KQIs.
• As assigned, deliver training related to quality control tools as required.
• All other duties as needed or assigned.

Benefits

• Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:
• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO)
• Employee recognition awards
• Multiple ERG’s (employee resource groups)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees