R&D -Quality Manager -Beijing

Job description

Who we are?

As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.

Why start your career path in Sanofi?

Here, you can:

·  Copperate with strong, independent technology group and experience digital & innovative ways of working
·  Be viewed as a trusted partner, shared goals and quality work

What you can contribute?

The purpose of the Quality Manager(QM) role is to be a quality advocate to the designated team within Clinical Study Unit(CSU) who works with the management and quality leadership to implement quality initiatives and drive continuous improvements. The individual is to ensure PAI readinsess of the projects in the CSU level. In addition, the QM deeply involved in the department’s quality system management work. As a seninor expert, the QM can work as the mentor of the AQM.

Quality Control and Planning

·  Develop and implement quality control plan for assigned projects 
·  Identify and assess risks through in-house document review and on-site quality control visit, work out corrective & preventive actions to mitigate the risks and ensure proper implementation of the actions by project management team and site monitoring team
·  Conduct process reviews based on quality data and trends
·  Provides quality related consultations
·  Conduct quality review on the CRO managed studies

Quality Mangement

·  Perform ongoing risk assessment in area of responsibility to identify perform/compliance gaps relative to current regulations and company standards, procedures & guidelines. Recommends robust corrective & preventive actions(CAPA) at regional level.
·  Be an expert in CAPA management, support/educate the business in developing robust CAPA and monitors thorough to resolutions for the following:
·  Deviation management/Root cause investigation
·  Audit response management
·  Inspection response management
·  Participates in developing quality indicators for area in SRMP.
·  Ensure that all defined quality system processes are effectively deployed and continually kept up at local level.
·  Support management in the resolution of quality related issues

Quality System

·  Be an expert on local regulations and international guidelines and provides interpretation and gives direct input into the medical quality system.
·  Owner of quality related procedures at regional level as assigned.
·  Support the development of the local SOPs to ensure alignment with local laws and regulations.
·  Support the self-check of the department quality system/process.
·  Support implementation of quality system locally by providing interpretation of requirements when consulted.
·  Support the CSU regular system audit
·  Be the initial point of consultation on SME related question for area of responsibility.
·  Communicates changes in local regulation to business customers and partners within CSU.

Inspection Readiness / Inspection Management

·  Liaise with monitoring team to prepare pre-approval inspections
·  Escalate serious GCP non-compliance /scientific misconduct activities to CROM and participate in investigations when necessary
·  Participate the local GCP inspections
·  Lead and coordinate PAI preparation and report response for local (China/TW/HK )HA inspection

Global Quality network

·  Involve in global quality network, as back up of contact person

What you should have?

·  Bachelor Degree or above in Medical/Pharmaceutical/Science or equivalent     
·  Good knowledge of spoken and written English
·  Minimum of 4 years of experience in clinical trial operation, at least 3 years of experience in quality management.
·  In-depth knowledge of SOPs, CRF, ICH/GCPs.

If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency:

·  Good organizational, interpersonal and communication skills
·  Good judgement and decision-making skills
·  Strong influencing and negotiation skills
·  Ability to work in matrix teams in an open and professional manner
·  Strong organizational/prioritization skills for the management of multiple concurrent projects.
·  Strong leadership capability

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.