Position can be based in Cambridge, Framingham or Waltham
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health. Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company that is dedicated to improving health and driving back disease by making innovative medicines accessible to people around the world.
Our extensive research and development efforts encompass a wide range of therapeutic areas that are in line with public health issues, trends and the most pressing health needs.
Sanofi US, along with the other US affiliates, Genzyme, Sanofi Pasteur, Merial and Chattem, employs more than 17,000 people across the country.
Commitment is our Strength. Ready to grow together.
The Global IS Quality & Validation Expert
The Global IS Quality & Validation Expert provides Computerized System validation and IS best practices advice, guidance and approval for key regulated GxP or strategic systems that impact R&D. She/he will be responsible for ensuring compliance through coordinating all validation activities in projects and change controls.
The Quality & Validation expert will participate in the creation, evolution and approval of the IS Quality framework and Quality Documents and facilitate compliance with Corporate and R&D policies, procedures and guidelines through training and coaching.
She/he will support the R&D IS organization in internal and external audits and inspections as subject matter expert for Validation and Quality/Compliance processes.
The position requires a detailed knowledge of validation requirements within the Pharmaceutical / Biotechnology industries. Knowledge of the Sanofi Computerized system methodology and quality system is necessary. The employee must remain current in international regulatory requirements with respect to GxPs and other regulations.
Duties & Responsibilities:
Computerized Systems (CS) Validation:
- Provide validation expertise to support Computer system methodology development and evolution.
- Advise and guide project and application teams on and approve validation activities in collaboration with Business Quality.
- Ensure compliance of projects and applications with applicable Regulatory and internal requirements by leading validation and testing strategy, risk assessments and validation planning and closeout.
- Provide training and support to projects teams on CS methodology and validation as necessary.
- Provide quality / validation leadership of change management and resolution of production issues for key/critical applications in collaboration with Application / Solution Owners and Business Quality
- Participate in the creation, evolution and approval of Validation related Policies, Guidelines and Procedures to ensure compliance with internal and external regulations (both within R&D IS or in the scope of the IS Function in collaboration with representatives from other IS Units).
- Ensure compliance with R&D Quality and validation policies, procedures and guidelines
- Participate in the creation, evolution and execution of Quality, Process or Validation related training programs to improve R&D quality, compliance and efficiency
Audits and Inspections:
- Act as the IS Quality/Validation focal point/subject matter expert for regulatory inspections as required.
- Work with Business System owners, Business Quality and IS Solution Center representatives during regulatory inspections to support audit activity as well as address and guide corrective action plans to improve compliance
- Participate in and support of GxP CS related internal or external audits.
- Organize, plan and conduct quality audits of vendors/suppliers (external)
- Coordinate and communicate CS validation questions/comments/issues raised by regulatory authorities during inspections.
Proactively work with IS Solution Centers and/or Business Partners to
- Plan for project and application validation/compliance support and
provide awareness / training on Quality and Compliance-related topics
Provide expertise for the development, evolution and harmonization of quality and validation processes within R&D and across Sanofi IS Units.
Budget, Resource allocation, and Reporting:
- Planning and forecasting validation project workload and resource requirements.
- Provide status, KPI and monthly indicators.
- Provide input to the development of the departmental budget.
Act as role model for company values.
Adapt to changing work environment.
Organize and manage global projects and teams of moderate scope and complexity.
Execute complex tasks of medium scope with little or no supervision.
Problems are broadly defined and solutions require choosing from multiple alternatives.
Independently provide project solutions and/or input to a variety of problems.
Build strong customer relationships, influence stakeholders, and resolve conflicts with stakeholders within workgroup with tact and diplomacy. Influence decisions outside of their workgroup.
Achieve effective communication in complex global organization.
Contribute to the development of team members goals. Coach others within workgroup.
Demonstrate ability to work across geographies in multiple countries and to interpret regulations for compliance.
Cultural sensitivity and capability to network and build social capital regionally multiple functional areas.
Demonstrate ability to lead a high impact or change initiative relative to Quality / Compliance in all parts of the organization
Key Internal/External Relationships:
Routinely communicates and networks with R&D management and other stakeholders globally including:
- Within and outside of the IS function on project teams.
- Business Quality on project teams and during audits/inspections
Communicates and collaborates outside of R&D with:
- Colleagues from other Sanofi business entities or IS Units
- Regulatory authorities
- Global Quality
- Industry colleagues #LI-SA