Clinical Quality Operations Manager

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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

• 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

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