Quality Assurance Sr Analyst

Sanofi US; São Paulo; Presencial; BRL 80.000 - 100.000; Tempo integral

Resumo da oferta

A global pharmaceutical leader in São Paulo is seeking a Quality Assurance Sr Analyst to perform oversight of Contract Manufacturing Organizations, ensuring compliance with quality standards. This role involves assessing GMP processes, leading quality reviews, and supporting product releases. Candidates should have a Bachelor of Science degree and experience in pharmaceuticals manufacturing. Excellent communication in Portuguese and English is essential.

Serviços

Competitive salary

Career growth opportunities

Collaborative work environment

Qualificações

• Experience in a quality role in pharmaceuticals manufacturing.

Responsabilidades

• Perform quality oversight of CMOs and partners managed by EM&S Brazil.
• Conduct quality assessments of portfolio-related GMP processes.
• Lead CMO quality reviews and contribute to risk mitigation.
• Support product market releases ensuring compliance.

Conhecimentos

Excellent communication

Organizational skills

Fluent Portuguese

Intermediate/Advanced English

Spanish (plus)

Formação académica

Bachelor of Science degree

Pharmacist preferred

Descrição da oferta de emprego

Quality Assurance Sr Analyst

• Location: São Paulo (SP) – sede
• Prazo Determinado (até 30/04/2026)

About the job

The EM&S Brazil QA Analyst performs direct quality oversight of Contract Manufacturing Organizations (CMOs) managed by the hub to ensure that manufacturing operations are conducted in accordance with GMPs and the quality agreement in place.

The position is the direct contact with CMOs for quality matters. It also interacts with functional units of EM&S LATAM, Brazil affiliate functions and M&S sites, and other organizations within Sanofi.

The QA Analyst contributes to the establishment and continuous improvement of EM&S LATAM Quality System on specific domains, providing support for implementation and management of the quality systems.

EM&S is a consolidated organization managing outsourced Sanofi products, operating in each region through virtual sites to ensure proximity with CMOs. It engages in network optimization and builds strong relationships with partners.

We extend Industrial Sanofi limits in installed capacity and technologies, ensuring quality and regulatory compliance, customer service and cost efficiency through strong tactical principles and internal compliance guidance.

Main responsibilities

• Performs quality oversight of CMOs and partners (licensors) managed by EM&S Brazil, including monitoring CMO compliance via GMP documentation review, remote contacts and onsite visits/audits. Serves as the primary quality reviewer of events such as change controls, deviations and complaints, including associated investigations and CAPAs.
• Performs sound scientific, quality and regulatory assessments of portfolio-related GMP processes (manufacturing processes, validations, stabilities, etc.) to provide the CMOs with a Sanofi position.
• Completes or assesses, according to established quality agreements, product quality reviews.
• Leads CMO quality reviews.
• Contributes to the CMO quality risk ranking establishment and leads associated mitigation initiatives.
• Supports country quality units in completing product market releases of EM Brazil supplied portfolio, ensuring key information is available to ensure compliant distribution.
• Contributes to the design and maintenance of quality agreements established with quality units. Participates in CMOs qualification initiatives, including initial assessment, due diligences, audit process and establishment of Quality Agreements.
• Performs quality oversight of material suppliers and GMP service providers.
• Identifies and communicates potential or confirmed critical quality events to management to ensure rapid escalation.
• Contributes to the implementation and maintenance of the hub QMS (Quality Management System) by designing and maintaining different quality systems.
• Defines and leads the entity third-party audit program, including scheduling, audit team member selection, audit outcome assessment and follow-up of action plans.
• As a member of the EM&S LATAM team, works according to approved procedures and predefined goals.
• Maintains a positive work atmosphere by promoting cooperation with third parties, internal customers, collaborators, coworkers and management.

• Maintain knowledge of and comply with the principles of Ethics and Integrity, Sanofi policies and codes of conduct regulating the pharmaceutical market.
• Comply with and promote Sanofi Health, Safety and Environment (HSE) policies to prevent accidents, reduce health risks and environmental impact.
• Support Sanofi Diversity & Inclusion strategy and initiatives to ensure equal opportunities for all employees and partners.

About you

• Education: Bachelor of Science degree. Pharmacist preferred.
• Experience: in a quality role in pharmaceuticals manufacturing
• Skills: Excellent communication and organizational skills.
• Languages: Fluent Portuguese and Intermediate/Advanced English. Spanish is a plus.

Why choose us?

• Opportunity to work with cutting-edge technologies in a global pharmaceutical leader
• Collaborative and innovative work environment
• Career growth and development opportunities
• Competitive salary and benefits package

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com.

Attention to the Phrases Below

*Always aimed at the safety and well-being of our employees, proof of COVID-19 vaccination is an essential item for all employees, being present on the list of admission documents.

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