Specialist I, Supplier Quality

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi has added new facilities to our global industrial footprint. These production units (Modulus) represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.

Fully digitalized, our Modulus Facilities will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our facility will help improve people’s lives by giving them faster access to more treatments.

Main responsibilities

The Supplier Quality sub-team is under the remit of the Site Quality Department. The team is responsible for providing Quality oversight Third Party selection and qualification criteria and advise on compliance-related actions in response to audit findings.

The Supplier Quality Specialist will be responsible to ensure that all third-party activities comply with relevant legal and regulatory requirements. Partner with the Global Quality and counterparts from other Sanofi sites for third party management, such as establishing and maintaining the quality technical agreements with third parties. The Specialist, Supplier Quality will primarily focus on providing Quality oversight to all supplier qualifications and materials qualification at Sanofi to meet Sanofi global quality standard requirements and fulfil the applicable regulatory expectations. The Specialist, Supplier Quality shall be experienced in solving complex problems, possess strong understanding of cGMP operations and well-versed in multiple quality systems (including change notification, change controls, deviations/CAPAs, laboratory investigations, document management system, Material technical assessments).

The Specialist, Supplier Quality shall:

• Evaluate and qualify new Third Party and when applicable, certifying Third Party based on their quality systems, capabilities, performance history and Quality Control expertise.

• Ensure that all third-party activities comply with relevant legal and regulatory requirements.

• Ensure proper documentation and record-keeping of all third-party quality activities and communications.

• Drive continuous improvement initiatives with Third Parties to enhance product quality and process efficiency.

• Develop and maintain Quality agreements and Technical Specification with Third Parties, outlining quality expectations and responsibilities.

• Establishing an annual auditsprogram of third-party facilities to assess compliance with applicable regulatory requirements (GMP / GDP) and internal documents.

• Identify and mitigate risks associated with Third Parties through risk assessments and implementation of corrective actions.

• Ensure the resolution of quality issues related to Third Parties, including audit observation, deviations, non-conformances, and Third Party complaints.

• Monitor the progress and timely implementation of any CAPA addressing quality issues or supporting continuous improvement.

• Support the material qualification process during technology transfer projects, ensuring successful deliverable completion and operational efficiency

Working hours –

• Personnel must be able to work office hours (weekdays) on site to support operational activities.

About You

Qualifications / Requirement

• Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with a minimum 3-5 years’ experience in quality management systems in the pharmaceutical or biotechnology industry. Experience in Veeva, SAP, managing contract testing laboratory, managing suppliers and service providers and audits will be an advantage.

Skills and Experience

Experience

• Experience in quality management systems in the pharmaceutical industry.

Skills

• Ability to analyze complex data, identify trends, and make data-driven decisions to improve quality and compliance.

• Strong verbal and written communication skills to effectively interact with third-party suppliers, internal teams, and regulatory bodies.

• Proficiency in conducting thorough and effective audits of third-party suppliers to ensure compliance with quality standards and regulations.

• Excellent problem-solving abilities to address and resolve quality issues, including root cause analysis and implementation of corrective actions.

• Strong project management skills to oversee multiple quality initiatives, manage timelines, and ensure successful completion of projects.

• Fluent in English, both written and spoken.