Sanofi Group Contract Mfg Quality Specialist, Westborough, MA in Waltham, Massachusetts
Contract Manufacturing Quality Specialist, Westborough, MA
External Supply Quality Assurance (ES QA) is the quality unit responsible for GxP oversight of
Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacture,
testing, and transport of Sanofi products. ES QA staff interact with functional units within Specialty
Care Quality (SCQ), Sanofi sites, and other organizations within the Biologics 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 the quality or product supply.
• ES QA has responsibility for CMO activities related to products treating Rare Diseases, Multiple
Sclerosis (MS), cancer, and diabetes.
• ES QA is based in Waltham, MA with satellite offices in Haverhill, UK, Gent, Belgium and
• ES QA personnel may be based on-site at CMOs acting as a Person-in-Plant.
- The ES QA Contract Manufacturing Quality Specialist acts as the day-to-day liaison with internaland 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 establishedquality standards and the applicable marketing authorizations.• Manage quality systems, e.g. change control, deviations, complaints, and product investigations.• Modify, review, and ensure contractor quality standards and protocols for processing materialsinto partially finished or finished products meet Sanofi and GMP requirements.• Contribute to the completion of milestones associated with specific projects.
- Release product in accordance with approved specifications and procedures.• Monitor contractor compliance via GxP documentation review and on-site visits/audits.• Implement methods and procedures for inspecting, testing, and evaluating the precision andaccuracy of products and production equipment.• Compile data and write summaries for periodic product reviews, investigations, complaints, anddeviations.• Distribute applicable contractor documentation for Regulatory, Validation, and Subject MatterExpert review.• Interact with multi-functional internal and external project teams to ensure compliance.• Respond to technical and quality issues and handle the schedule and/or process-related conflicts.• Demonstrate understanding of the applicable US and global regulations related to the manufacture facture ofmedicinal products (small molecules and biologics).• Monitor contractor performance to established Key Performance Indicators (KPI) and reportadverse trends.• Provide guidance to less experienced staff, as applicable.
• May assist in vendor selection and evaluation.
• Provide QA project manager support for change controls and other projects.
• Develop and manage Quality Agreements between Sanofi and the contractor.
• Participate in contractor quality audits and verify any actions taken by the contractor in response
to audit observations are completed satisfactorily.
• Support program for maintaining performance metrics.
- Bachelor’s degree and 6+ years of experience in a cGxP or other regulated environment, to include 4 years in a Quality role.
- Master’s degree and 4 years of experience in a cGxP or other regulated environment, to include 2 years in a Quality role.
In-depth understanding of quality systems and current quality management tools.
Broad knowledge of EU/US cGMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory affairs.
Experience in Quality Assurance with focus on product release within a complex supply chain.
A working knowledge of manufacturing operations, aseptic processing, validation principles, Quality Control techniques and testing methodologies is beneficial.
The successful candidate will possess the following skills /competencies:
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 to multi-task effectively.
Problem solving and technical writing skills.
Special Working Conditions:
- 25% domestic/international travel.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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.