Clinical Quality Operations Manager

This role is for upcoming future opportunities that may arise at Fortrea.

Preference will be given to candidates residing on the East Coast.

Overarching Responsibilities:

In collaboration with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is responsible for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into client sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.

The incumbent will be responsible for the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach.

The incumbent will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Operational Quality Management

• Lead implementation ofquality by designand risk-based quality management (RBQM) in clinical trials.
• Serve as primary contact for trial teams on RBQM activities (e.g., risk assessment, CTQs).
• Ensure oversight of third-party activities, including vendor management and quality agreements.
• Support audit/inspection responses and drive cross-therapy area process improvements.
• Collaborate with CQOL to address emerging risks, especially in digital data management.
• Build strong stakeholder relationships across Clinical Development, QA, and global functions.
• Contribute to standardization of CQO tools and procedures.

Inspection Preparation and Management

• Maintain expertise in global GCP inspection requirements (FDA, EMA, MHRA, etc.).
• Lead/support inspections and act as regulatory POC when assigned.
• Develop and maintain inspection procedures, training, and strategy.
• Ensure cross-functional readiness for inspections and manage inspection plans.
• Track global inspection activity and escalate significant findings to senior leadership.

CAPA Management Support:

• Ensures that all actions and commitments related to audits and inspections are implemented in a timely manner. Tracks all inspection CAPA and regulatory commitments and checks evidence of completion.
• Ensures repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.
• Provides guidance and support for CCQMs regarding inspections at a country level sites that require a client headquarters input.

Other activities:

• Provides input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
• Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.
• Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.

Education:

• Bachelor's/ Master's Degree in Life Sciences or similar. Further formal education in quality management or business management is desirable.

Experience

• 6+ years in clinical research, including 2+ years in clinical quality and inspection management.
• Strong knowledge of clinical development, QMS, GCP/ICH, and global regulatory requirements.
• Experience with CAPA and risk management tools.

Skills

• Excellent communication, leadership, and project management skills.
• Strategic thinker with strong problem-solving and analytical abilities.
• Effective in cross-functional collaboration and inspection readiness.
• Skilled in summarizing audit/inspection findings and delivering lessons learned.

Pay Range:$95,000 - $150,000

Benefits:All job offers will bebased on a candidate's skills and prior relevant experience, applicabledegrees/certifications,as well as internal equity and market data.Regular,full-timeor part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.

Learn more about our EEO & Accommodations request here.