Job Description

Digital Quality team is accountable to ensure that Digital projects, products, processes and services are delivered with the right level of quality and in compliance with Sanofi and regulatory expectations, supports audits and inspections as well as self-assessments/ reviews and contributes to the evolution of the Digital Quality Management System.

The Digital Quality Lead \xe2\x80\x93 Supply Chain & Data has the accountability of the Digital Quality operations on applications in the scope of M&S Supply Chain and Data unit perimeter, by:

Using expertise to steer the Quality & Compliance activities to systems that are critical to the business

Allocating resources from Quality internal teams and Quality center of service in order to ensure Quality support to projects delivered, and manage risks

Optimizing the Quality & Compliance support across the perimeter, partnering with the Digital Quality units

Scope supported (details not exhaustive):

M&S Supply Chain scope with key programs: SmartSC, SCCORE and M&S Data domain: M&S Data foundations, M&S AI & GenAI pilots and implementation.

This is a transversal role which requires interaction with several internal and external stakeholders such as Digital Units, Global quality/Business quality, Internal Control, Internal Audit, Data Privacy office, External Stakeholders are Regulatory Agency Inspectors, External Auditors, Supplier and Service Providers. This makes this position unique as requires interaction and understanding of different needs, flexibility, and ability to share Quality expertise and implementation of best practices. You will be based in Sanofi Hyderabad and contribute to current Sanofi Digital transformation and accelerate the integration of Digital Technology into Supply Chain business applications & Data transformation end to end for our Industrial Activities.

Manage Quality operations support delivery for the scope

Be the primary partner for Digital leads and Business stakeholders for the domain to identify, and address Quality requirements and alerts

Define, plan and implement appropriate Quality support to Digital teams

Manage demands for project & application Quality support and allocate resources with the Quality center of service

Ensure Quality by Design and on-time delivery of Quality activities across the project lifecycle

Ensure compliance of the development, delivery & maintenance of Business Information Solutions

Provide support, guidance and training with respect to applicable regulatory (e.g. GxP, SOX) and internal requirements for the design and implementation of controls, the application of project methodology and validation/qualification process.

Define validation/qualification strategy and provide advice, guidance, and approval on validation activities in collaboration with Business Quality and project teams following a risk-based approach.

Pilot delivery of validation activities with Quality center of service and ensure quality of service

Provide guidance and oversight for the management of CAPA related to the supported systems.

Support Risk Management through identification, characterization, and development of mitigation plans, in collaboration with Digital Units and other stakeholders.

Support the Digital Organization during audits and inspections.

Collaborate with Business System owners, Business Quality and Solution Center representatives to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective/preventive action plans to improve compliance and effectiveness of the Quality Management System

Support SOX audit campaigns on applicable controls (IT general controls and IT dependencies), and associated remediation plans

Support internal control campaigns, quality assessments and reviews for assigned projects and applications to ensure compliance and / or application of best practices.

Contribute to the development of continuous improvement of the Digital Quality Management System, Computerized System Lifecycle methodology and IT Processes

Experience: Computerized Systems compliance in regulated environments (GxP and SoX) such as Pharmaceutical/ biotechnology industry in a global, cross-functional, multi-national environment.

Soft skills:

Demonstrated leadership and ability to effectively influence and make decisions

Strong Problem solving, decision making, transversal collaboration and communication skills.

Intermediate change management skills

Influencing, coaching and critical thinking

Risk-based decision-making mindset.

Technical skills:

Advanced knowledge of Risk Management, Project & Application management, compliance of computerized systems (e.g. GxP, SOX).

Understanding of Digital solutions in Pharmaceutical and experience with industrial Manufacturing processes is a differential.

Education:

Life science, Quality, computer science or related scientific or technical discipline. Ability to understand Digital Products in Pharmaceutical environment.

Language:

Excellent written and oral communication in English, including ability to effectively educate various audiences on quality and compliance topic.

Pursue progress, discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s be those people.

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