Quality Control & Stability Manager, Belgium

About the Opportunity

Join Sanofi Specialty Care External Supply, location Ablynx Ghent as a Quality Control & Stability Managerto provide GxP oversight for Contract Laboratory Organizations used in product release and stability testing, support method transfers, qualifications, and analytical lifecycle management, as well as management of supply of critical reagents and controls.

About the Sanofi Specialty Care External Supply Unit

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 staff interact with functional units within Specialty Care Quality (SCQ), Sanofi sites, and other organizations within the Specialty Care network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality or product supply.

About growing with us

In this role you will….

• Collaborate with senior management, peers and teams to establish GxP priorities that are aligned with business objectives. Work with internal/external project team members to incorporate the appropriate elements of quality, equipment and production into QA/QC strategies

• Engage in execution of major GxP projects and ensure adherence to schedule, e.g. technology transfers, process performance qualifications (PPQ), stability programs, global regulatory submissions, annual product reviews, implementation of quality system

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

• Manage sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments and manage qualified materials program.

• Manage the operation of Stability and Quality release testing programs across parts of a multi-product portfolio, managing timelines to meet corporate goals.

• 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

About you

Qualifications/ Education & work experience

• BS / MS in a scientific discipline

• 8+ years of pharmaceutical / biotechnology industry / experience in a similar role working with external partners (e.g. contract laboratories and suppliers)

• 4+ years 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 with an ability to apply such knowledge effectively within a team/project environment.

• Demonstrate leadership capabilities, but also the ability to actively listen and influence in a cross-functional set up within a matrix organization

• Software and IT affinity – advantageous

• Excellent communication, collaboration skills and ability to work cross-functionally

• Team player, enthusiastic, independent and self-motivated

• Sense for problem solving, initiative, quality, accuracy and detail

• Oral and written fluency in English and Dutch (preferred)

Inspire your Journey: what Sanofi can offer you:

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.

• An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).

• An individual and well-structured introduction and training when you onboard.

• You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.

• As a globally successful and constantly growing company, Sanofi provides international career paths as well.

This is our Sanofi. Discover yours.

If you feel you have the required experience, please apply NOW! Alternatively contact maria.kmetyova-ext@sanofi.com directly for more details.

https://www.sanofi.com/en/careers/

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.