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Sanofi Group Senior Quality Engineer in Framingham, Massachusetts

The department provides leadership, guidance, and oversight of the Quality Policy, Dossier Compliance, External inspections, Self Inspection, and Risk Management programs for the Framingham site. Maintenance of Dossier Compliance and Maintenance of the compliance of the State-of-the-Art for all site product lines. Quality Risk Management Program (site risk profile, quality performance indicators, metrics, training program); guidance to the Site Quality Council ensuring site overall compliance status; Compliance oversight of site Self-inspection program. Functions include Auditing, reports, developing, approving, and tracking corrective and preventative (CAPA) actions to inspection observations. Leadership and coordination of site external inspection readiness and Regulatory Authority communication. Functions include facilitation, management, and support of all site external regulatory inspections; leadership and coordination of the inspection response; approval and track inspection commitments; approval of Regulatory Authority response to the inquiry, submissions, and notifications. The Department also provides quality/GMP guidance to site cross-functional personnel (i.e. QA, QC, Manufacturing, Facilities, Engineering, MSAT, L&D, etc.) ensuring resolutions are achieved for quality compliance escalations and potential risks.

POSITION OVERVIEW WITH KEY RESPONSIBILITIES

  • Work closely with functional teams including QA, QC, Facilities, Engineering, MSAT, Manufacturing, and Planning/Logistics to provide guidance and expertise in the following topics or projects: Interpretation of cGMP, regulatory requirements, directives, and guidelines from Corporate Quality management and/or from established regulatory agencies as pertaining to day-to-day (e.g. failure investigations, procedure clarification) and/or inspectional decision-making.

  • Review and perform Quality Assurance approval of complex responses, and CAPAs.

  • Apply and interpret current regulations, requirements of Sanofi standards, and local procedures, to ensure records are clearly and appropriately justified. Support Internal Audits of site departments and systems to identify areas at risk for external observations.

  • Guide in the development of responses to observations and provides approval for responses.

  • Approve internal audit responses and CAPA. Approve external regulatory agency-related CAPAs. Generate technical reports (e.g. PPR, QMR, SRPR) Facilitate and/or participate in formal risk assessments.

  • Review and assess explicit documentation and data received in support of quality systems (e.g. CAPA, CCR, Risk) to ensure compliance with internal quality procedural requirements and corporate requirements, and appropriate conclusion are supported with data evidence provided (e.g. RCA, validation report).

  • Support continuous improvement of quality and manufacturing systems using LEAN tools and implementation of actions arising from continuous improvement events. Perform the review and approval of technical documents and determine interrelated impacts on processes and systems.

  • Ensure completeness and correctness of items such as engineering studies, Validation protocols, Technical Reports, Engineering drawings, and MBRs/SOPs.

  • Work independently with little or no supervision and exercises considerable discretion in determining objectives and approaches to significant organizational projects or assignments

  • Demonstrate an ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

  • Being honest and treating people with respect and courtesy.

  • Constantly striving to make Sanofi a great place to work, and a company respected for the quality of products and performance of people.

  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

LEADERSHIP QUALIFICATIONS

Although this position does not have any direct reports, the role requires emerging leadership skills for activities such as facilitation of Quality Risk Management, Auditing, continuous improvement, Site Quality Council, etc. As such the preferred qualification is demonstrated leadership in conducting cross-functional team meetings and/or projects.

BASIC QUALIFICATIONS

  • Bachelor's Degree and a minimum of 6 years of experience working in a regulated GMP environment or Master’s Degree and a minimum 3 years of experience working in a regulated GMP environment.

  • Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing, Technical Support, Facilities, Engineering or Automation Knowledge of regulatory health agency regulations (FDA, EMA, etc.)

  • Experience in CAPA, change control, risk management, auditing

PREFERRED QUALIFICATIONS

  • Experience with LEAN manufacturing (problem-solving, LEAN tools) or comparable continuous improvement systems

  • Experience auditing digital systems Experience participating in international external regulatory health agency inspections Knowledge of regulatory agency enforcement trends

  • Experience with project management

  • Special Working Conditions Ability to gown and gain entry to controlled classified areas

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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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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