Senior Quality Specialist

About this Opportunity

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.

SCES Q has responsibility for CMO and CLO activities related to products treating Rare Diseases and Blood Disorders, Multiple Sclerosis (MS), cancer, and diabetes.
SCES Q has offices based in Waltham, MA US; Frankfurt Germany; Haverhill, UK; Ghent, Belgium and Naarden, the Netherlands
SCES Q personnel may also be located remote or on-site at CMOs acting as a Person-in -Plant.
The SCES Q Contract Manufacturing Quality Specialist Senior acts as the day-to-day liaison with internal and external customers for quality related activities.
Ensure GMP compliance of Sanofi products manufactured and/or tested at a contract facility.
Ensure all aspects of product manufacturing and/or testing are reviewed versus established quality standards and the applicable marketing authorizations.

Key Accountabilities

• Support CMO batch release
• May assist in vendor selection and evaluation.
• Provide QA project manager support for change controls and other projects.
• Develop and manageQuality Technical Agreements between Sanofi and the contractor.
• Participate in contractor quality auditsand verify any actions taken by the contractor in response to audit observations are completed satisfactorily.
• Support program for maintaining performance metrics

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people withrespect and courtesy.
Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Your Education & Experience

• Bachelor’s degree and 5-8 years of experience in a cGxP or other regulated environment, to include 3 years in a Quality role.

OR

• Master’s degree and 4+ years of experience in a cGxP or other regulated environment, to include 2 years in a Quality role.
• Experience in Quality Assurance with focus on product release within a complex supply chain.

Your Language Skills

• Excellent communication (both written and oral) skills in English is a requirement
• German language knowledge would be beneficial

Your Competencies

• In-depth understanding of quality systems and current quality management tools.
• Broad knowledge of US/EU cGMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory affairs.
• In-depth understanding of biologics/mAbs manufacturing processes
• A working knowledge of manufacturing operations, aseptic processing, validation principles, Quality Control techniques and testing methodologies is beneficial.
• Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion.
• Attention to detail and good organizational skills.
• Strong written and verbal communication skills and the ability tomulti-task effectively.
• Problem solving and technical writing skills.

Play to Win Behaviors

• Stretch to go beyond the level we have operated at up until now
• Putting the interest of the organization ahead of my own or those of our team
• Act in the interest of our patients and customers
• Take actions instead of waiting to be told what to do
• Role model our 4 values: teamwork, integrity, respect, courage

We offer you:

• immediately a permanent contract with Sanofi
• an attractive salary package with meal vouchers(worth €8), a DKV hospitalization insurance,..
• evaluations
• educations
• career opportunities in a growing organization where involvement, integrity, entrepreneurial spirit and collaboration are driving values