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Digital Quality Systems and Compliance Lead

Cambridge, Massachusetts

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Overview

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Culture: Play to Win

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    Growth

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    Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • 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.

  • 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.

  • 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.

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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

JOB SUMMARY:

Our mission is to support the Sanofi business units by delivering differentiated services and solutions that help patients, physicians, care takers, payers as well as Sanofi to better take care of patients and provide an improved outcome to the healthcare system. Our services and solutions sit on top of our market leading technology platform which we continue to evolve.


We have recruited top talent in the field of Digital Health to help transform care in Diabetes, Specialty Care and beyond in the areas of Drug+ apps. Our team has released an FDA certified class II medical device titration application, MyDoseCoach, in countries such as India, Mexico & Colombia and we are gearing up for other software applications across the diabetes and specialty care journey.

The Digital quality operations team is  seeking a Digital Quality System and Compliance Lead to  provide direction and leadership from within the Digital Device Quality group to Product Management, Engineering & Operations and Regulatory Affairs, to ensure the Quality System works optimally and complies with global external regulations and standards. The position maintains and improves Medical Device  Quality Management System and supports the execution of key Quality System processes such as audits (Internal and External), CAPA, training, change management and management review.

JOB QUALIFICATIONS:

Soft skills:

  • Analytical skills and ability to understand complex problems and structure into logical streams for resolution

  • Decision making ability

  • Ability to operate in an international, cross-company and cross-functional environment.

  • Communication and inter-personal skills necessary to build trust, confidence, and collaboration toward shared objectives

  • Flexibility in approach and ability to adapt to changing circumstances when required.

  • Language - Business fluent (written and oral) in English is required.

  • Cooperate Transversally:  collaborating effectively with peers, stakeholders and partners across the organization to positively impact business results

  • Leadership experience required (direct leadership, project leadership)

  • Act for Change, embrace change and innovation and initiate new and improved ways of working

  • Commit to Customers: Understand, meet and exceed internal and external customer expectations to create positive impact

  • Strive for Results, seek ongoing improvement to create sustainable added value

Formal Education And Experience Required:

  • Bachelors Degree and 5+ years of related work experience with a strong understanding of specified functional area, an equivalent combination of education and work experience

  • 3+ years Medical Devices/Pharma experience is required

  • CAPA experience is required

  • Experience working with Software as  Medical devices standards/regulations;  Wide application of technical principles, practices, procedures and Industry standards (e.g. ISO13485, 21 CFR 820, EU MDR).

  • Experience with  Medical Device Risk Management ISO 14971 are a plus;

  • Strong understanding of business unit function and cross group dependencies/ relationships.

  • Experience on problem solving, where analysis of data requires evaluation of identifiable factors.

  • Extensive knowledge of global GMP and regulatory requirements as related to the medical device process is required

  • Experience with tools such as JIRA and  MasterControl are a plus

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Lead, maintain and improve a Medical Device Quality Management System(focused on software as a medical device products) and support the execution of key Quality System processes such as audits, CAPA, training, change management and management review.

  • Lead programs and projects related to quality system evolution.

  • Provide functional leadership to the site quality systems operations, digital quality operations teams and Digital Site Quality Head.

  • Establish and maintain the quality manual.

  • Lead and manage the development of efficient cross-department synergies and communication to address quality alerts.

  • Lead on the analyses of new quality system related corporate requirements and regulations.

  • Establish, monitor and maintain/ improve the quality system and associated processes (e.g. CAPA, Change Control, Purchasing Controls, Document Controls, Audits, Management Review).

  • Initiate / Review/ approve quality system records related to the QMS (e. g. CAPA, Change Control).

  • Monitor compliance and drive the updates of policies and procedures with regulatory requirements (e.g. compliance with FDA, ISO 13485, EUMDR, TGA, Anvisa, PMDA, NMPA, and emerging market regulations and standards etc).

  • Lead the Digital device quality team members by engaging them to develop plans and resolve issues in the scope of the SaMD Quality management system, gaining their commitment and holding individuals accountable for agreed plan.

Product compliance:

  • Partner with stakeholders to drive solutions to address gaps

  • Provide interface to Sanofi global regulatory functions and other site functions with regards to regulatory affairs related topics, e.g. regulatory questions in development project, submission preparation, maintenance of product documentation.

  • Monitor and analyze quality system key performance indicators (KPI) to ensure corrective actions are effective and report to executive management, notably SaMD Product compliance performance indicators.

  • Inspection readiness and support , Lead and participate in Notified Bodies inspections, corporate and customer audits (providing back room and front room support, providing input related to the SaMD Quality management system).

  • Liaise with other functions, lead and provide input to progress investigations or corrective actions where appropriate.

  • Training: manage the SaMD QMS training curriculum and activities, and training deployment approach.

KEY INTERNAL & EXTERNAL RELATIONSHIPS:

Internal Stakeholders:

  • Global Regulatory affairs

  • Global Quality/Business Quality

  • Pharmacovigilance

  • Internal Controls

  • Internal Audit

  • Data Privacy Officer

  • Digital units leaders

  • Cyber Security

External Stakeholders:

  • Regulatory Agency inspectors

  • External auditors

  • Suppliers / Service Providers

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.

Fully vaccinated, 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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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.

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