Clinical Quality Operations Manager- FSP

Parexel • Southport, NC

100d

About The Position

The Clinical Quality Operations Manager (CQOM), in collaboration with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations (CQO), 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 CQOM will be responsible for the development of Quality Plans to implement 'Quality by Design' within clinical Development Programs, using a risk-based approach. The CQOM will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Requirements

• Bachelor’s/ Master’s Degree or equivalent in relevant health care area.
• Minimum of 6 years of relevant experience in clinical research.
• At least 2 years of direct experience with developing and managing clinical quality systems.
• Profound knowledge and understanding of clinical development programs and clinical trial processes.
• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
• Experience with delivering effective CAPA management solutions.
• Experience with risk management tools and processes within the clinical quality framework.
• Superior oral and written communication skills in an international environment.
• Excellent project management and organizational skills.
• Excellent teamwork and leadership skills, including conflict resolution expertise.

Nice To Haves

• Further formal education in quality management or business management.
• Ability to lead cross-functional teams of business professionals.
• Ability to think strategically and objectively.

Responsibilities

• Develop Risk Assessment and Categorization Tools (RACT) and Quality Plans in partnership with the Clinical Trial Team (CTT).
• Perform a Therapeutic Area (TA) level review of quality plans and risk mitigation approaches periodically to identify emerging signals or trends.
• Ensure comprehensive oversight of all activities delegated to third parties.
• Facilitate and monitor CTT oversight of vendors.
• Develop, review and revise quality agreements with business partners.
• Ensure essential elements of the quality management system are in place for studies conducted with non-commercial organizations.
• Facilitate and oversee responses to audit and inspection observations.
• Analyze data across therapy areas to identify signals and trends and develop process improvement strategies.
• Develop skillsets to recognize and respond to new and emerging risks through technology.
• Build and enable effective working relationships with key stakeholders.
• Contribute to the standardization of Clinical Quality Operations procedures, tools and templates.
• Maintain current regulatory inspection knowledge as it relates to GCP inspections.
• Lead and support GCP inspections worldwide.
• Collaborate with other CQOMs to provide comprehensive oversight of the TA.
• Develop, update, and maintain GCP inspection procedures and guidelines.
• Ensure cross-functional teams are informed and prepared for Regulatory Health Authority inspections.
• Maintain and QC the global inspection tracking system.
• Act as the subject matter expert for Inspection Management.
• Develop the inspection management plan for each assigned Regulatory Health Authority inspection.
• Ensure timely implementation of actions related to audits and inspections.
• Track all inspection CAPA and regulatory commitments.

Benefits

• Equal opportunity employer.
• Comprehensive drug development capabilities.
• Global regulatory expertise.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees