Principal QC & Stability Associate

About the job

Our Team:

Specialty Care External Supply Quality (SCES Q) is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi products.

SCES Q has responsibility for CMO and CLO activities related to products treating Rare Diseases and Blood Disorders, Multiple Sclerosis (MS), cancer, and diabetes

Main responsibilities:

• Responsible for supporting the management of Contract Laboratory Organizations (CLOs) for release and stability of drug substance, drug products and diluent testing.

• Coordinate sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments.

• Coordinate and manage qualified materials program.

• Coordinate/Lead multiple site/global projects and represent QC across organizations.

• Contribute to the operation of Stability and Quality release testing programs across a multiproduct portfolio, managing timelines to meet corporate goals.

• Execute reagent requests from testing labs (including in-country testing, method transfers) and arrange internally shipment (many countries require special documents)

• Generate release Certificate of analysis from external testing results, assuring compliance to internal specifications.

• Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for commercial and clinical drug product

• Contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA;

• Contribute to stability and quality sections of Annual Product Review Collaborate with Quality, internal functional areas, and CLOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports

• Track sample testing status; enter results into LIMS as needed; and Compile and generate stability data tables and reports for commercial and clinical products for annual product reviews

About you

Basic qualification requirements:

• BS/MS in a scientific discipline with a minimum of 8 years of experience in the pharmaceutical /biotechnology industry.

• Quality Control (QC) experience is necessary, ideally working with external partners (e.g. contract laboratories and suppliers);

• LIMS experience preferred.

• In-depth knowledge of FDA/EMA regulations and compliance and can apply that knowledge effectively within a team/project environment

Preferred Qualifications:

• Advanced degree is preferred, along with experience ideally working with external partners (e.g. contract laboratories and suppliers);

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