Sanofi Group Quality Systems Specialist, Cambridge, MA in Cambridge, Massachusetts

Key Accountabilities

  • Oversees Quality System tasks in multifunctional, international environments.

  • Establishing annual audit management of “Internal Audits” and “External Audits” (supplier audits)

  • Performing of GMP relevant training issues

  • Support maintenance of MEDTech Quality System status

  • Support quality system relevant subsystems (e.g. corrective and preventive actions, change controls, design controls, and Purchasing Controls)

  • Provide expert assessment to management of critical and potentially critical aspects with regard to quality system

  • Supporting and follow-up management review activities

Requirements;

  • Associate Degree with 4 years experience or equivalent.• Proficient in usage of quality systems (e.g. Design controls, management review, Quality By Design);• Good knowledge of international medical device regulations; • Proficient in usage of risk management tools (e.g. FMEA, FTA) acc. ISO 14971;• Good knowledge of international quality standards ISO 13485 & QSR• Able to work independently• Ability for cross functional work with other global functions GRA, IQC, GMA, GPE, Diabetes Division, Marketing, R&DHuman relations ability is a critical requirement for the job of a Quality Manager. Communication skills and sensitivity are key aspects to keep good working relationship with the different sites and global/regional functions of Sanofi-Aventis• Ability to overcome discrepancies in interpretation of quality requirements without compromises. Ability to talk round and negotiate ‘grey’ areas.• Ability to build up human relationships and a basis of mutual trust between quality and project teams• Ability to enter into highly different cultural and regulatory backgrounds worldwide with ‘diplomatic sensitivity’.• Capability to present the results of the quality assessments to all levels of Local/Regional/Global Management.• Flexibility in approach and ability to adapt to changing circumstances when required.

  • Excellent team player and team leader, decision making and problem-solving skills.

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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life