Sanofi Group Quality Document Manager in Bridgewater, New Jersey
The Quality Document Manager leads/participates in projects for which changes and improvements to clinical business processes and related Quality Documents (QDs) are expected. These documents are required by Regulatory Authorities in compliance with Good Clinical Practice (GCP) and related regulations, are essential for the conduct of international clinical trials, and are subject to inspection by Health Authorities.
The Quality Document Manager collaborates with the Project Manager to evaluate the scope of process and QD deliverables, and to identify expected business process and QD impacts on clinical platform end users.
The Quality Document Manager leads/participates in activities related to business process definition and mapping, in collaboration with Subject Matter Experts (SMEs) from impacted departments/entities, following a defined methodology.
The Quality Document Manager is responsible for developing QDs (i.e. Standard Operating Procedures, Process Maps, Working Instructions and Supporting Documents – checklists, templates, forms), according to the agreed plan and using corporate templates and writing rules. The Quality Document Manager is responsible for managing the QD review process, and following up as necessary with SMEs and Business Process Owners (BPOs). He/she is responsible for peer Quality Control (QC) of documents, management of the approval workflow in the Quality Document Management System (QDMS) and publication of the documents through Information Letters.
The Quality Document Manager also supports business representatives to develop Business Technical Documents (BTDs), by advising on content and structure. He/she coordinates BTD review with the impacted departments, consolidates SME comments, manages QC and approval workflow in the QDMS, and publication through Information Letters.
The Quality Document Manager also supports audit and inspection preparation activities, by providing customized QD lists and copies of requested QDs. Further to audits and inspections, he/she works with Clinical Quality Assessment (CQA) to implement improvements and corrections to QDs.
The Quality Document Manager is also involved as an SME or Project Lead in continuous improvement projects managed by Clinical Quality & Continuous Improvement (CQ&CI), related to departmental processes, systems or day-to-day operations.
Bachelor degree or higher, ideally in scientific/health-related field
Minimum of 5-7 years’ experience in the pharmaceutical industry in clinical operations roles (e.g. study management, document management, monitoring, data management, medical writing, auditing)
Experience working within a global team/environment
Good knowledge of international Good Clinical Practice (GCP) guidelines (e.g. ICH) and current regulatory requirements (e.g. FDA, EMEA) related/applicable to the conduct of clinical trials
Quality-focused, with an in-depth understanding of Sanofi quality system and R&D organization
Knowledge and proven experience in harmonization, optimization and documentation of business processes
Experience of reading, understanding, interpreting and developing/designing process maps, flowcharts and diagrams
Proven experience in managing, writing and reviewing global clinical R&D Quality Documents
Excellent communication and interpersonal skills, to collaborate with departmental associates and project teams, and to support end-users and external partners
Excellent written and spoken English, in order to interact effectively in an international environment
Team leadership and facilitation skills: ability to effectively lead global teams through discussions on complex and potentially controversial topics
Detail-oriented; able to control the reliability and quality of documents
Results-driven; able to multi-task, prioritize assignments and manage a wide range of operational and strategic activities in parallel
Ability to anticipate issues and assess downstream impacts, and proactively implement corrective measures, including possible escalation to senior management
Fully conversant in a variety of software packages (such as Microsoft Word, Outlook, Powerpoint, Excel, Access
Familiarity with process design tools (e.g. MEGA), document management systems (e.g. QDMS, Geodeplus, DOMASYS), information sharing systems (e.g. sharepoint)
Certified in Business Process Management (BPM) methodology
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
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