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CHC Global Quality - Compiègne DC Quality document & training Coordinator

AT Sanofi U.S.
Sanofi U.S.

CHC Global Quality - Compiègne DC Quality document & training Coordinator

Compiègne, France

CHC Global Quality - Compiègne DC Quality document & training Coordinator

Compiegne

About the job

At Sanofi Consumer Healthcare, we have one shared mission - we work passionately, every day, to 'serve healthier, fuller lives' now and for the generations to come.

In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees' mission and operate responsibly from both a social and environmental point of view.

Everything we do is centered around people's interests - our consumers, our customers, healthcare professionals, and our employees - across the world.

We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.

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We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.

CHC Global Quality is a team of highly motivated people to build the state-of the-art quality with an E2E approach across CHC business areas and ensure best quality and compliance for our patients safety.

Within Global Quality, the Global Science Quality Team is the gatekeeper of quality in Science (Development & Regulatory, Pharmacovigilance, Medical/Clinical and Innovation projects) activities:
  • Lead and manage the implementation of the CHC quality management systems within CHC Science to ensure activities and data are managed in compliance with the Global Quality standards and applicable regulatory requirements.
  • Coordinate quality activities and continuous improvement initiatives across in alignment with top management expectations and business requirements towards the construction of the FMCH company
  • Provide the Chief Quality Officer with good confidence in quality compliance
  • Partner with functions to build embedded and FMCH Quality
  • Ensure hands-on support on all quality activities within CHC Science.

Main responsibilities:

The Compiegne Development Quality Document & Training Coordinator reports to the Opella Global Head of Development Quality and is responsible that a consistent and effective quality Document system and training management system are implemented in Compiègne Development Center (DC) for regulated dev activities.

He/she owns and secures the Global DC QD common tracker and administrates CONNECT DEV entities.

Manage a robust process driven Quality Document system in Compiegne Development center
  • Ensure compliance to the global Document management SOP in Opella (periodic review, templates, writing rules, document types...)
  • Working closely with the development center teams,
    • lead and coordinate the local Quality Document workflow to ensure timely delivery of effective versions, involving SMEs
    • withdraw or coordinate withdrawing of obsolete Quality Documents
    • lead and coordinate the timely Global Quality Standards gap assessment
  • Identify and propose opportunities to optimize the quality document system in Compiegne Development Center (robust architecture, quality of document content, reduction of number of documents...)
  • Ensure team awareness on quality document management process and role & responsibilities
  • Support local teams with CONNECT CMS
  • Support audit & inspection preparation and participate as needed.
  • Maintain the local document tracking tool
  • Ensure the availability and reconciliation of the quality documents at the workstation
  • Report QD KPIs and perform trend analysis

Own the Global Common QD tracker (a global file that provides the overall picture of QD system across development center, facilitate identification of opportunities for simplification, provide process-driven QD guidance, follow up GQ gap assessment progress & in gap assessment..)
  • Ensure appropriate mapping with Opella Playbook processes
  • Add global document based on GQ newsletter to monitor global progresses
  • Perform QC checks and follow up with local Dev center Quality managers to provide big picture of local documents
  • Continuously improve the file

Execute best in class training management for Compiègne Dev Center
  • Ensure compliance to the global Personel Qualification SOP in Opella
  • In close collaboration with the Dev Center leaders, design & and maintain the local Training matrix
  • Maintain and assign Training matrix in CONNECT
  • Support local teams with CONNECT LMS
  • Monitor training completion
  • Report training KPIs and perform trend analysis
  • Develop relevant training event/material in alignment with business needs
  • Coordinate CVs & Job-desc management & Secure storage
  • Support local managers in setting on-boarding plans for new comers
  • Ensure team awareness on Training management process and role & responsibilities

Administrate the Dev Center Owning Entities in CONNECT globally
  • Manage access rights
  • Maintain settings and Owning Entity parameters
  • Connect with Global Quality BPOs

Partner with Compiègne Development Centers Teams and key stakeholders
  • Work closely with SMEs to ensure alignment of business processes and Quality document system
  • Participate to LT meetings to provide update on Quality Document and Training and escalate risksn issues and concerns
  • Contribute to building FMCH company through simplification and optimization of QD and training management
  • Foster the Quality mindset within Development centers

As a member of Global Quality
  • Partner with quality system process owners to ensure smooth interaction, compliance and consideration of development specific requirements and/or constraints
  • Support new quality systems roll out in Compiegne Development Center
  • Escalate quality risk & concerns to direct manager in appropriate timelines
  • Manages special projects assigned by supervisor as relevant
  • Participate to quality meetings (e.g. Quality Community, extended-GQLT...)
About you
  • Experience: experience in Document Management and Training management , and in digital system administration
  • Soft skills: recognized leadership, business partner, networking capability, proactivity, autonomy, good communication skills (ability to present information & procedure in a clear, complete and understandable manner)
  • Technical skills: excellent skills in IT tools in general and Excel in particular. Ability to master new IT tool and resolve technical issue independently and without difficulty.
  • Education: (not mandatory)
  • Languages: English is compulsory (regular interaction with other Dev center in the world)

Why choose us?
  • 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.

Client-provided location(s): 60200 Compiègne, France
Job ID: Sanofi-https://jobs.sanofi.com/en/job/compiegne/chc-global-quality-compiegne-dc-quality-document-and-training-coordinator/2649/18765134656
Employment Type: Other