Cadre assurance quality - R&D CMC Synthetics

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Job title: Cadre Assurance Quality - R&D CMC Synthetics

Location: Sisteron, France

Remote working: Up to 20% remote working possible

Travel expected: 5-10%

About the job

Ready to shape the future of medicine? Join our R&D GQO team in Sisteron where we implement a quality management system adapted to early development phases. As a Cadre Assurance Quality - R&D CMC Synthetics, you'll make critical quality decisions based on scientific approach and rigorous risk assessment, balancing compliance requirements with necessary agility. Your expertise will be instrumental in ensuring our R&D CMC activities meet the highest quality standards while maintaining the flexibility needed for innovation.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Key responsibilities:

Manage Quality Assurance withint he R&D CMC Synthetics Sisteron

Maintain R&D quality management system processes within &D CMC Synthetics scope (compliance with regulatory requirements and internal standards, quality procedures and documents, Conducts self-inspections and monitors corrective actions implementation)

Coordinates investigations following deviations and non-conformities

Manage Change control

Review Clinical batch manufacturing records, Manufacturing Master Records or Technical Conditions

Performs Quality Agreements for subcontractors; Manages supplier quality issues and monitors corrective actions; Conducts supplier audits

Supervise analytical activities for R&D products: reviews and approves analytical methods and specifications; Participates in out-of-specification results and deviation investigations; Supports analytical method transfers

Prepares and participates in internal and external audits or regulatory inspection preparation

Conducts quality training

Applies group HSE policy within scope of activity; Promotes HSE best practices

About you

Experience:

3-5 years experience in quality assurance in pharmaceutical industry, particularly in clinical API manufacturing

In-depth knowledge of GxPs applicable to clinical API manufacturing and analysis

Education:

Mastery of quality processes and continuous improvement tools

Educational Background: Master's degree in scientific field (pharmacy or chemistry) or equivalent

Soft and technical skills:

Knowledge of pharmaceutical regulations

Analysis and problem-solving capability

Strong communication and project management skills

Rigor and organizational skills

Ability to work in multidisciplinary teams

Proficiency in quality IT tools

Languages:

Good level of English (B2/C1)

Why choose us?

Give life to science miracles as part of a forward-thinking, supportive team

Discover countless opportunities to develop your talents and advance your career through promotion or cross-organizational assignments

Benefit from a well-thought-out package of benefits that recognize your contribution and amplify your impact

Take good care of yourself and your family with comprehensive health and wellness benefits, including high-quality healthcare, wellness programs, and parental leave of at least 14 weeks regardless of gender

Play a key role in establishing best practices within our production unit

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law.

#LI-FRA

#LI-Hybrid

Pursue

progress, discover

extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

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

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

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