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SCES QA Compliance Manager

Waltham, Massachusetts

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Overview

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

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"One of the best things about Sanofi Genzyme is the consistently fun and dynamic work environment that I get to be a part of."

Kristin Ouimet Regional Business Manager

"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

POSITION OVERVIEW

SUMMARY:

  • The SCES Quality Compliance Manager leads the management of the Internal (self-Inspection program, ensuring that a risk based approach is applied to determine areas of audit focus and managing corrective actions and follow ups.

  • This position is also responsible to maintain the sites Inspection Readiness program ensuring information and personnel are prepared and coordinated to facilitate an efficient and successful execution of activities in support of any external audit events.

  • The SCES Quality Compliance Manager is also a key contributor in hosting and coordinating audit events including both external Regulatory bodies, Internal corporate entities and any other licensing or associated officials.

  • Specialty Care External Supply Quality (SCES Q) is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi products.

  • SCES Q staff interact with functional units within Specialty Care Quality (SCQ), Sanofi sites, and other organizations within the Specialty Care network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality or product supply.

  • SCES Q has responsibility for CMO and CLO activities related to products treating Rare Diseases and Blood Disorders, Multiple Sclerosis (MS), cancer, and diabetes.

  • SCES Q has offices based in Waltham, MA US; Frankfurt Germany;; Ghent, Belgium and Naarden, the Netherlands

  • SCES Q personnel may also be located remote or on-site at CMOs acting as a Person-in -Plant.

  • Within the SCES Quality organization, the SCES Compliance Team is responsible for Risk Management, Compliance, Continuous Improvement initiatives and the Management support and monitoring of Internal (self-inspection) and External audit activities including any associated Regulatory actions.


Core Responsibilities:

  • Key interface towards the external auditing organization worldwide to provide point of contact for information, documentation and scheduling. Additionally, will provide both internal and external communication on audit activities.

  • Tracks and analyses trends and data on audit information.

  • Provides input for the execution of global and local Quality Agreements (QAgs) ensuring compliance with all legal/contractual obligations.

  • Manages compliance with current GMPs regulatory and corporate requirements for all regulated activities within scope.

  • Provides identification, assessment, control and communication of risks identified within scope of responsibility.

  • Ensures the audit findings and response activities are consistently and timely managed.

  • Ensures implementation and evaluation of corrective and preventive actions to address systemic issues.

  • Implements self-evaluation and continuous improvement tools.

  • Fosters a strong mindset of Quality culture across the SCES organization.

  • Provides guidance on Quality improvement initiatives across the SCES organization.

  • Provides technical support and guidance to senior management on strategic topics where his/her knowledge, experience, and skills are critical to decisions of strategic impact on products, processes and systems.

  • May performing audits of CMOs and suppliers as well as self-inspections including planning, organization, performing, reporting and follow-up in cooperation with other functions.

  • Represent department or organization in project team meetings related to corporate initiatives.

  • Interact with project teams and cross functional groups.

  • Ensure that site practices are consistent with corporate quality standards as appropriate.

  • Interface with vendors/external suppliers as required.

  • Interface with external regulatory agencies as required.

Additional Responsibilities

May be assigned a leadership role (e.g. Primary Process Owner or Site Process Owner) in a Community of Practice, e.g. Self Inspection / Inspection Readiness.

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 our products and services. This includes:

  • Respecting the laws and operating within the applicable 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 its people and products.

  • 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.


Leading People:

  • Sanofi's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others.

  • They are versatile learners and courageous decision makers.

Leading the Business:

  • Sanofi’s leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

Delivering to Customers

  • Sanofi's leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.

Basic Qualifications:

  • Bachelor's degree and 5-7 years relevant experience, or

  • Master's Degree and 3-5 years relevant experience

  • 5+ years supervisory and/or management experience in a quality environment

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.

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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