Contract Manufacturing Quality Specialist Senior
Northborough, Massachusetts
Overview
From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.
Success Profile
Do you have what it takes for a successful career with Sanofi?
- Courageous
- Results-driven
- Proactive
- Problem-Solver
- Leadership
- Team player
Culture: Play to Win
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Growth
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Innovation
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Efficiency
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Collaboration
Benefits
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Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
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Financial
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
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Culture
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
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Work/Life Balance
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
Quote
"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."
Shannon Resetich
US Head Rare Diseases & Blood Disorders
"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."
Mouhamed Gueye
US Head Medical Rare Blood Disorders
Responsibilities
About the job
Our Team:
New opportunity available within Sanofi Specialty Care for a Contract Manufacturing Quality Specialist Senior role!
Our team supports production and release of Finished Goods (FG) at US and EU CMOs for Rare Blood Disease products. Quality comes first with our team, and we work in an Autonomous Production Unit (APU) structure under two different Autonomous Production Teams (APT) – one for US and one for EU. In this role you will be accountable for supporting the APTs in manufacturing authorizations and release of finished goods and liaison with internal and external customers for quality related activities.
Main responsibilities:
Support release of 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 and accuracy of products and production equipment
Compile data and write summaries for periodic product reviews, investigations, complaints, and deviations
Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review
Interact with multi-functional internal and external project teams to ensure compliance
Respond to technical and quality issues and handle schedule and/or process-related conflicts
Demonstrate understanding of applicable US and global regulations related to manufacture of medicinal products (small molecules and biologics)
Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends
May assist in vendor selection and evaluation
Provide QA project manager support for change controls and other projects
Develop and manage Quality Technical 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
About you
4+ years’ experience in a cGxP or other regulated environment, to include 2-3 years in a Quality role preferably
Experience in Quality Assurance with focus on product release within a complex supply chain
In-depth understanding of quality systems and current quality management tools
Broad knowledge of EU and/or US cGMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory affairs
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
Problem solving and technical writing skills
Good team-player with excellent communication skills
High-level proficiency with Microsoft Office, PowerPoint, Excel, Outlook and ERP systems (SAP…)
Up to 25% domestic/international travel might be required
Bachelor’s and/or master’s degree in procurement, supply chain, business administration or similar
Oral and written fluency in English
About the job
Our Team:
New opportunity available within Sanofi Specialty Care for a Contract Manufacturing Quality Specialist Senior role!
Our team supports production and release of Finished Goods (FG) at US and EU CMOs for Rare Blood Disease products. Quality comes first with our team, and we work in an Autonomous Production Unit (APU) structure under two different Autonomous Production Teams (APT) – one for US and one for EU. In this role you will be accountable for supporting the APTs in manufacturing authorizations and release of finished goods and liaison with internal and external customers for quality related activities.
Main responsibilities:
Support release of 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 and accuracy of products and production equipment
Compile data and write summaries for periodic product reviews, investigations, complaints, and deviations
Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review
Interact with multi-functional internal and external project teams to ensure compliance
Respond to technical and quality issues and handle schedule and/or process-related conflicts
Demonstrate understanding of applicable US and global regulations related to manufacture of medicinal products (small molecules and biologics)
Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends
May assist in vendor selection and evaluation
Provide QA project manager support for change controls and other projects
Develop and manage Quality Technical 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
About you
4+ years’ experience in a cGxP or other regulated environment, to include 2-3 years in a Quality role preferably
Experience in Quality Assurance with focus on product release within a complex supply chain
In-depth understanding of quality systems and current quality management tools
Broad knowledge of EU and/or US cGMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory affairs
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
Problem solving and technical writing skills
Good team-player with excellent communication skills
High-level proficiency with Microsoft Office, PowerPoint, Excel, Outlook and ERP systems (SAP…)
Up to 25% domestic/international travel might be required
Bachelor’s and/or master’s degree in procurement, supply chain, business administration or similar
Oral and written fluency in English
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.
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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, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com
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.
