Clinical Quality Operations Manager

Fortrea

Clinical Quality Operations Manager ensuring quality by design principles and compliance in clinical trials management. Collaborating with teams and overseeing regulatory inspection readiness and management activities.

Posted 6/24/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $120,000 - $132,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Responsible for process and performance management related to the delivery of the operational function(s), as assigned.
Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
Single point of contact for clinical trial teams for all activities associated with risk-based quality management (RBQM).
Perform a TA-level review of quality plans and risk mitigation approaches to identify any emerging signals or trends.
Responsible for ensuring comprehensive oversight of all activities delegated to third parties.
Facilitating and monitoring CTT oversight of vendors.
Developing, reviewing and revising quality agreements with business partners.
Ensuring essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organisations.
Facilitating and overseeing responses to audit and inspection observations as appropriate.
Analyzing data across therapy areas in order to identify signals and trends and then developing and implementing appropriate process improvement strategies.
Maintaining current regulatory inspection knowledge regarding GCP inspections by regulatory agencies worldwide.
Contributing to the development and/or revision of Sponsor policies, SOPs and training materials.
Developing the strategy for management/support for GCP inspections of Sponsor products.

Requirements

What you’ll need

Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
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.
Fluent in English, both written and verbal.
Experience in Risk Management and Quality Management in Phase I.
Relevant clinical research experience in a pharmaceutical company or CRO: Minimum of eight (8) years relevant clinical research experience in a pharmaceutical company/CRO.
Thorough knowledge of drug development process.
Thorough knowledge of relevant SOPs, ICH, and GCP guidelines.
Thorough project management, change management, line management experience, and quality control experience highly desirable.
Individual is familiar with on-site monitoring activities (including pre-study, initiation, routine monitoring, and closeout visits), with on-site monitoring experience being highly desirable.
Relevant quality management experience: Detailed knowledge of all aspects of GCP guidelines and regulations.
Demonstrated ability to separate critical from non-critical GCP issues.
Demonstrated effectively balance quality and speed in complex situations.
Relevant leadership and process skills: Demonstrated ability to work in a team environment.
Demonstrated ability to work under pressure and requires minimal supervision.
Strong interpersonal and communication skills.
Strong negotiation skills and ability to influence stakeholders across functions.
Strong analytical skills.
Excellent planning and organizational skills.
Excellent oral, written and presentation skills.

Benefits

Comp & perks

Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
401(K)
Paid time off (PTO)
Employee recognition awards
Multiple ERG’s (employee resource groups)

ATS Keywords

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Hard Skills & Tools

clinical researchquality management systemsregulatory inspectionsGCPICHCAPA managementrisk managementproject managementchange managementquality control

Soft Skills

interpersonal skillscommunication skillsnegotiation skillsanalytical skillsplanning skillsorganizational skillsleadership skillsteamworkability to work under pressureability to influence stakeholders