Sanofi Group Clinical Inspection Readiness Leader in Bridgewater, New Jersey
The Clinical Inspection Readiness Leader (CIRL) is an “expert” leader responsible to lead Clinical Inspection Readiness (IR) and Pre-Approval Inspection (PAI) activities and to identify strategic solutions for continued improvement across clinical, where needed. He/She can also be a Clinical Quality Risk/Alert Leader for assigned risks. Overall, the CIRL leads large transversal projects that support inspection readiness for which significant changes/improvements to business processes are expected across R&D and beyond.
As we are piloting expansion of our this CIRL role into a true quality partnership with the clinical teams, this position may also have primary responsibility to establish and maintain a working relationship in partnership with clinical teams and units to support GCP compliance during the conduct of studies, and to propose, contribute to and review the audit programs to be performed.
Leads the development of Inspection Readiness and Pre-Approval Inspection Preparation with respective clinical study team leaders and applicable Co-Development Partners and CROs.
Provides required leadership and support pre, during and post regulatory agency sponsor-monitor inspection with the goal to ensure clinical teams are able to withstand the scrutiny and questioning of a sponsor monitor pre-approval inspection.
Defines and develops strategies to work with cross functional departments to build ‘inspection readiness’ and consistently identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/study reporting and transversely across processes.
Develop and obtain quality-driven, risk-based metrics; evaluate and report metrics forecasts and trends to ensure internal and external adherence to inspection readiness expectations Leads strategic initiatives, either autonomously or collaboratively, that target continuous improvement and achievement of operational excellence to support inspection readiness.
May need to function as Clinical Quality Risk manager (CQRM and be in charge of analyzing the different signals / events related to clinical activities to profile the quality risks, establish their impact and propose and manage their mitigation
If expansion to quality partner on the clinical team is realized, the main additional responsibilities would include being the primary link with operational teams for all clinical quality aspects specific to a project. Main additional responsibilities include Inspection Management, GCP Compliance Support, project/study level quality risk management, deviation management and providing input and contribution to GCP audit programs
Bachelor degree or higher in a relevant scientific/health-related field.
Minimum of at least 10 years’ experience in the pharmaceutical industry, with a minimum of 6-8 years’ experience in GCP clinical and/or GCP quality operations-related roles (e.g., GCP auditing, clinical trial monitoring, trial management or Pharmacovigilance).
Demonstrated ability to lead complex projects/assignments.
Extensive knowledge of Research & Development with past experience in clinical operations, preferably global clinical trial management and/or GCP Quality and FDA/EMA GCP inspections. In-depth knowledge of GCPs, ICH and, if applicable, Sanofi SOPs.
Quality focused with a high degree of personal accountability and commitment.
Demonstrated skills in self-motivation, taking initiative and working independently.
Strong knowledge on project management (global clinical projects; clinical process improvement projects).
Strong knowledge of international good clinical practices (ICH) and understanding of current regulatory requirements (FDA, EMEA) related/ applicable to the conduct of clinical trials, understanding of FDA Compliance Manual & EMA Compliance Manual.
Knowledge about requirements of New Drug Application (NDA)/ Market Authorization Application (MAA) submissions and e-submissions.
Strategy focused with ability to extrapolate detail without losing sight of big picture.
Results driven with attention to detail and quality while overseeing and connecting with contributing stakeholders.
Excellent team leadership, presentation, interpersonal and communication skills (written and verbal).
Rigor, diplomacy and good analytical abilities.
Strong facilitation skills: ability to lead effective cross-location and cross-functional meetings, through discussions on complex and potentially controversial topics.
Demonstrated ability to bring consensus among diverse cross functional teams and to drive results within established timelines.
Able to manage and negotiate complex and/or sensitive.
Demonstrated ability to anticipate problems/ changes impacts, consequences, and delays; work proactively and take the initiative for corrective measures.
Ability to analyze trends and determine strategic improvement needs; ability to execute and monitor the implementation and progress of such improvement processes.
Ability to multi-task, handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise with ability to prioritize assignments in accordance with assigned project deadlines.
SharePoint knowledge & experience.
Innovation and analytics for data management and metric development.
Experience with FDA, EMA or other regulatory inspections of sponsor, investigator sites, or CROs.
Sanofi US Services, 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.