Sanofi Bridgewater , NJ 08807
The TES Expert develops operational expertise and approaches to improve collaboration and alignmentwith internal customers and stakeholders & external partners or vendors. The TES Expert identifies and evaluates opportunities for process and operational improvements to maximize added value to business activities.
The TES Expert- Operational Quality implements a Quality Management System in Trial Operations, which provides an integrated and flexible system that can systematically plan and achieve quality objectives linked to strategic and tactical goals to expedite drug development and delivery. He/She implements risk-based approaches to quality management and providers oversight as per ICH E6 (R2).
The Quality Management Expert:
Ensures that quality aspects are applied in trial operational processes to achieve high standards of quality. He/she is primary contact for the expertise domain to represent Trial Operations in transversal projects or working groups within Clinical Science & Operations, or with the other Scientific Core Platform units, or Support Functions.
Defines and implement vendor oversight practices and indicators to monitor quality of clinical trial operations deliverables.
Puts in place successful vendor quality selection criteria and contract design, defines quality monitoring and manages risk minimization when outsourcing clinical trials.
Participates in effective vendors' services oversight to ensure that quality service level agreement are defined, implemented and in control. (indicators, etc).
Coordinates transversal vendors' oversight activities to identify / collaborate in the identification of risks, quality issues. He/she coordinates analysis of business and quality risk and provides guidance to the Study teams at different steps of study conduct to ensure quality in operational activity.
Collaborates with Trial Operations Steering Committee to work prospectively to mitigate operational and quality risks and alerts, implements/ drives the implementation of global corrective and preventive actions.
Coordinates and provide support / Lead Operational Excellence Units for Pre-Approval Inspection and submission activities for Trial Operations.
Lead harmonization and optimization of quality operational processes and standards and fosters innovation and continuous improvement, promote and implement Lessons learned (learning organization).
Collects, analyze audit/ inspections findings for Trial Operations to propose corrective and preventive actions.
Coordinates in Trial Operations preparation to audits and inspections activities. Supports study teams in audit/ inspection activities
Interacts with Quality Teams as TO Representative for quality risk management and clinical quality assurance.
Interacts with Transversal Vendor Management instances for vendor management quality aspects.
Requirements & Qualifications
Knowledge and Skills
Proved Clinical Trial Operations and Quality expertise
Quality focused and experience in Quality Management Systems
Strong knowledge of International Regulations / Guidelines / Good Clinical Practices pertaining to the pharmaceutical industry standards and practices
Strong knowledge and understanding of FDA Compliance Manual & EMA Compliance Manual
Knowledge about requirements of New Drug Application (NDA)/ Market Authorization Application (MAA) submissions and e-submissions
Self-motivated & results driven with attention to detail and quality while overseeing and connecting with cooperating departments; results driven in terms of timelines and quality
Effective people and team leadership skills/styles, including the ability to effectively serve as a change agent
Strong organizational skills, flexibility, diplomacy, efficient in matrix organization
Excellent interpersonal and communication skills (verbal and written) including a good customer- focus mentality needed to efficiently and effectively collaborate with departmental associates, project teams, other responsible and accountable key interfaces and SCP functions, and external partners
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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