Principal Expert I, Data Integrity & Compliance, EVF

Job description

Mission

Sanofi is preparing its future through an ambitious program named Evolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address business challenges. Digital will be one of the key topics to help EVF to reach its ambition. On top of it, Sanofi is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: “VIA will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+”.

In this context, we are looking for one Principal Expert I, Data Integrity & Compliance for our new site based in Singapore.

Key Accountabilities

The Data Integrity Program is key to ensure the compliance use of the digital initiatives. The Data Integrity & Compliance Lead is part of the Quality function, and dotted line manages all the site computerized system business & data owners for all domains. Reporting directly to the Head of Quality, the Data Integrity & Compliance Lead works closely with the respective EVF functional teams to provide oversight and guidance for data integrity and projects related to data integrity to achieve the site’s digital ambition while in compliance with data integrity requirements. In addition, the Data Integrity & Compliance Lead will lead the site self-inspection program to ensure the key compliance principles are embedded in the site processes and practices. He/she will also lead the site Quality Culture program, enabling the right Quality Culture to be embedded.

The mission described below, must be exercised in compliance with health, safety and environment of the site rules.

·  Direct and implement the strategic approach to site-wide data integrity assurance, including the identification and implementation of robust site and functional governance structure and processes. This is performed through a robust interpretation of world-wide regulatory requirements and trends, and translating these to the site roadmap in accordance with company strategic plans.  
·  Co-design and direct the implementation of the site internal inspection program, incorporating elements of DI and Quality Culture into the site GMP quality assessment.
·  Independently conduct assessment of the effectiveness of the entire site and functional management principles, and GMP processes and control, through structured self inspections and gemba walks, assisting the site management and functional teams in identifying and mitigating gaps and areas for improvement. The assessment outcomes will also be escalated to Head of Quality and Site Head to drive remediation of the gaps and leverage on opportunities observed.
·  Develop and implement the Quality Culture programs through a robust leverage of organisational psychology diagnostics. Develop and monitor the Quality Culture metrics to assess the health of the site Quality Culture. Promote a healthy Quality Culture by creating psychologically safe working environment for employees to raise and address concerns.
·  Deploy Risk Management Strategy for identification of DI and GMP quality assurance vulnerabilities.
·  Collaborate within the organization and externally to enable best practices and new points for consideration, and participate in Sanofi DI community of practice (CoP).
·  Partner with site computerized system business & data owners on Data Integrity related projects and initiatives. Coordinate cross-project activities of the site as they relate to Data Integrity activities. Understand project interdependencies, anticipate, and detect risks to programs and develop countermeasures, as needed.
·  Participate in Data Integrity related investigations and CAPAs to ensure the investigations are robustly conducted with comprehensive CAPA implemented.
·  Work with the site Quality System team to refine the site quality compliance roadmap through an analysis of site quality compliance inspection findings to identify root causes and areas of improvement.
·  Key subject matter expert during a regulatory inspection on site DI and self-inspection initiatives.
·  Coach and guide functional Heads, DI representatives and self-inspectors to effective self-assessment of DI and GMP quality assurance.
·  Coach and guide site staff in data integrity requirements, including investigation techniques as they relate to DI.

Education and experience

·  Bachelor’s degree in relevant discipline (Science, Engineering or IT related)
·  Minimum of 10 years’ experience in biopharmaceuticals or highly regulated environment
·  Minimum of 3 years of project management experience
·  Minimum of 3 years of experience with Data Integrity remediation and leading data integrity remediation efforts on a site and / or network leverage, and a good background in information technology and thorough understanding and knowledge of data integrity related regulatory requirements (i.e. Annex 11 and 21CFR11)

Key technical competencies and soft skills:

·  Experience as an internal or corporate quality assurance auditor
·  Solid knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and data integrity requirements.
·  Experience in or working within quality systems especially as it relates to data integrity, root cause analysis
·  Proficient in QMS and Quality Risk Management Principles.
·  Familiar with Digital 4.0 concepts and potential applications in Quality
·  Good knowledge of organization psychology, and have experience implementing site cultural programs
·  Exceptional communication and negotiating skills; strong presentation and facilitation skills.
·  Excellent operating skills including the ability to plan and organize the work to match resources and get the work done.
·  Strong Project Leadership skills driving compliance and accountability. Have experience managing medium to large scale site wide projects
·  Strong interpersonal relationships in order to establish the partnerships necessary for the development of an engrained Quality culture and the correct execution in transverse.
·  Adaptable and flexible with problem solving skills Highly motivated – ability to multi-task
·  Able to gown and gain entry to manufacturing, QC and Engineering areas
·  Experienced in facility start-ups will be advantageous

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.