Quality Assurance Manager
Sanofi

About the Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

The incumbent will be an integral part of the Sanofi R&D Global Quality Organization entrusted to ensure we our compliant with applicable GLP regulations and GCLP guidance, procedures, study plans, and Sanofi's QMS. This is accomplished through the independent inspection and auditing of both internal and external non-clinical studies and clinical biological sample analysis, processes, and facilities, and through the accurate reporting of audit findings. In addition, you will be a key representative of the team by providing quality guidance on assigned projects and quality issues.

Key Contributions & Activities

• Inspect and audit internal and external laboratory activities, support services, data, and reports.
  
• Prepare audit reports, assure corrective actions are complete and consistent with organizational objectives.
  
• Assess external vendors and suppliers contracted by Sanofi for GLP and GCLP activities to ensure appropriate level of compliance.
  
• Contribute to working groups at local and/or global level that work on the development of new concepts, techniques, and standards within Sanofi.
  
• Responsible for ensuring studies, raw data, reported results, and facilities comply with FDA, OECD GLP regulations or other health authority guidelines (e.g., GCLP), Sanofi policies and procedures, and industry standards as appropriate.
  
• Review quality documents including SOPs, policies, reports, methods.
  
• Participate in GLP QA Due Diligence activities.
  
• Review and approve equipment qualification and computer software validation deliverables as Business Quality Representative.
  
• Provide or assist with regulatory training activities.
  
• Assist as needed in internal or external inspections of site.
  

About you

Requirements & Qualifications

• Bachelor's degree in life sciences or related scientific field with a minimum of 8 years relevant industrial experience (e.g., toxicology, bioanalytical testing, biotech/pharmaceutical manufacture), with at least 4 years in a quality role (e.g. QA).
  
• Ability to work independently and to establish solid working relationships with staff of all levels and disciplines.
  
• Understanding of the GLP regulations and or GCLP principles a plus.
  
• Experience with non-clinical safety studies, clinical or bioanalysis sample analysis, and or the validation and performance of bioanalytical methods.
  
• Knowledge of industry practices pertaining to the validation and qualification of laboratory equipment, software, and or facilities.
  
• Knowledge of auditing practices including the ability to audit computerized data.
  
• Ability to manage multiple duties often under challenging timelines.
  

Terms of employment

• Full time hybrid
  
• Domestic and international travel required up to 20%
  
• Company business hours
  
• This position does not have any direct management of personnel
  

What makes this position unique?

You are member of the only GLP Quality group in the US. It is a small team with many responsibilities that will allow you exposure to a quality role that is involved with the development of products at Sanofi and will allow you to develop new skills. You will have the opportunity to directly contribute to process improvements and make changes that will benefit our partner groups and quality.

Benefits of working in this role

• Position supports career growth within the quality organization and provides development in regulatory compliance
  
• Opportunity to work with a variety of disciplines involved in development as well as exposure to global teams
  
• Work as a team with our partner groups to directly support Sanofi R&D and ultimately our patients
  

Location information

• Job is based in Cambridge, MA
  

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
  

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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