Clinical Quality Operations Manager

Clinical Quality Operations Manager – Fortrea Join to apply for the Clinical Quality Operations Manager role at Fortrea. We are currently seeking a Clinical Quality Operations Manager This full‑time, hybrid role is based in Canada. The individual must be located in Canada, fluent in French and English, and willing to work in the Montreal/Kirkland office twice a week. You will work with leading pharmaceutical, biotechnology, and medical device companies in critical stages of clinical development: establishing safety, tolerability, and pharmacokinetics of new drugs. What You Will Do You will utilize your skills, knowledge, and clinical judgment to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Key Responsibilities Ensure patient safety, high-quality data, and compliance with company requirements and regulations for all sponsor‑sponsored clinical trials. Oversee all CQM activities in the respective country/cluster under guidance of the Regional Director, Clinical Quality Management (RCQM). Implement local/global processes and procedures, identify opportunities for process improvement, and support continuous improvement initiatives. Support audits, inspections, quality control, and local training activities. Qualifications University/college degree (life science preferred) or certification in a related allied health profession (e.g., nursing, medical or laboratory technology) from an appropriately accredited institution. Experience A minimum of 6‑8 years of relevant experience in clinical research, including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred. Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations. Solid track record of initiating, planning and delivering projects and knowledge of project management practices. Demonstrated experience in leading cross‑functional teams. Experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement. Experience in managing audits and inspections. Experience in coordinating and delivering training sessions. Skills Superior oral and written communication and leadership skills in an international environment. Excellent project management, organizational and prioritization skills. Excellent teamwork skills, including conflict resolution expertise and discretion. Ability to analyze, interpret, and solve complex problems. Ability to think strategically, objectively, and with creativity and innovation. Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results. Regulations & Processes Local expert for ICH‑GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes). In close collaboration with local country operations management, manage the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local SOPs / Work Instructions. Local expert for any quality‑related local processes. Identify process gaps / opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary). Lead continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM and support or co‑lead continuous improvements activities at the global/regional level. Training Local training point of contact and liaison between local country operations and client L&D. In close cooperation with local country operations management, identify/coordinate local training needs. Support local trainings (as needed). Quality Control (QC) Activities Coordinate and oversee all QC activities, ensuring proper execution of the in‑house QC plan (IHQCP), QC visits (QCVs), and other QC checks. Perform QC activities (incl. QCVs) and conduct ad‑hoc site visits upon request. Identify local trends, perform root‑cause analysis (if necessary), develop local action plan, and share results and training with local country operations. Audits & Inspections Primary local point of contact for sponsor QA and regulatory agencies. Manage and support activities during audit or inspection preparation, ongoing, and follow‑up phases. Perform root‑cause analysis for audit findings, manage and track CAPAs, and coordinate responses to audit/inspection reports. Identify local trends, perform root‑cause analysis, and develop local action plan. Quality / Compliance / Privacy Issue Escalation Communicate/escalate quality/compliance issues and significant trends to local operations management and RCQM. Escalate significant quality/compliance issues and support investigations and reporting of serious breaches. Serve as local point of contact or support local POCO in case of privacy incidents. Clinical Supplies GCP Investigations Evaluate trends on clinical supply GCP inquiries and incorrect management of supplies. Coordinate GCP investigations related to supply inquiries and incorrect management. Supplier Qualification Lead local supplier qualifications and re‑qualifications of locally selected suppliers. Support QMS assessment for supplier qualifications and re‑qualifications. Sponsor Compliance & Privacy Steward Support implementation of divisional compliance/privacy initiatives and reporting at the local level. Communicate compliance/privacy concerns to local legal/compliance/privacy department and/or sponsor offices. Global / Regional Key Initiatives / Projects Support global/regional key initiatives/projects upon request of the RCQM. Benefits Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) 401(K) Paid time off (PTO) Employee recognition awards Multiple ERGs (employee resource groups) Physical Demands / Work Environment Work environment: office environment with exposure to electrical office equipment. Frequent travel to client/site locations with occasional domestic and international travel. Travel requirements: 15% Physical Requirements Ability to sit for extended periods and operate a vehicle safely. Repetitive hand movement of both hands with ability to make fast, simple repetitive movements of fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software. Light to moderate lifting and carrying of objects up to 15‑20 lbs. Regular and consistent attendance. Varied hours may be required. Learn more about our EEO & Accommodations request here. Seniority level Mid‑Senior level Employment type Full‑time Job function Management and Manufacturing #J-18808-Ljbffr