Quality Documents Expert
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities:
- Supporting the Pharmacovigilance, Medical and Transversal Quality Operations (TQO) quality documentation (QD) and its related training
- Promoting harmonization of quality standards
- Communicating on processes and tools related to quality documentation
- Ensure the preparation and maintenance of Pharmacovigilance and Medical Quality documents (QDs) in line with global quality standards
- Promote a single consistent approach in sanofi processes:
- - Contribute to the establishment and monitoring of the annual QD plan. Ensure sanofi architecture of QDs is applied.
- - Foster simplification and avoid redundancy of Quality Documents
- - Contribute to the establishment and monitoring of the annual QD plan. Ensure sanofi architecture of QDs is applied.
- Ensure timeliness and quality of Quality documents in the Content Management System (CMS):
- - Ensure documents are following the correct workflow steps
- - Perform a technical review of each document ensuring writing rules are followed
- - Monitor workflow steps of each document until approval. Remind authors, reviewers and authorizer as needed.
- - Communicate on the approval and effective dates of Quality Documents
- - Ensure documents are following the correct workflow steps
- Ensure the delivery of training of the concerned QDs by creating training link in the Learning Management Systems(s) and preparing e-learning material with SMEs
- Lead or participate to specific projects related to process or tools improvements, assess impacts, set up and monitor action plans
- Maintain up-to-date the documentation describing Quality Documents activities
- Perform gap assessments on Global QDs and follow-up Corrective Actions and Preventive Actions (CAPA) plan
- Provide guidances and support to countries on the management of their local QDs
- Contribute to the preparation and communication of Quality Documents metrics and Key Performance Indicators (KPI)
- Support inspections and audits by providing required data on due time, participating to interviews, contributing to Root Cause Analysis (RCA) and CAPA proposal
- Collaborate with key stakeholders from Quality Document network
- Bachelor’s degree (Certified health professional degree e.g. Nursing, Pharmacist, Health Science degree)
- 2+ years’ experience in GxP Quality system management, Quality Documents or Medical/Scientific writing
- 2+ years’ experience in Pharmacovigilance and/or medical activities
- Knowledge in International Pharmaceutical Regulation e.g. GVP, GCP, ICH
- Advanced use of Microsoft Word® and Excel®
- Advanced use of Content Management System (CMS)
- Use and develop dashboards
- Project Management skills
- Team player that cooperates transversally in a cross-functional environment
- Analytic, proactive, and problem-solving mindset
- Self-motivated, able to relentlessly prioritize, plan effectively and autonomously
- Organized and detail oriented while seeing the big picture
- Efficient time management
- Customer focus
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
#LI-GZ #LI-Onsite
#vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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