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Sanofi Group Manager Quality Management Systems SCES in Waltham, Massachusetts

POSITION OVERVIEW:

Specialty Care External Supply Quality (SCES Q) is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs) 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 Biologics 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 is based in Waltham, US (MA) and Frankfurt, Germany with satellite offices in Haverhill, UK and Ghent, Belgium.

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

  • Within the SCES Q organization, the SCES Quality Management System (QMS) Group is managing CAPAs, Deviations, Change Controls, Document control & Record management, Periodic Document Review, Periodic Product Reviews as well as Data Integrity, Computerized systems LCM and other related quality systems.

  • SCES QMS is leading the Standard remediation, Quality Maturity Index assessments, GRT/ GRIC process, Quality Management Reviews (QMR and ASQSR) and, if applicable, Functional area reviews for the entire SCES organization.

  • SCES QMS maintains the Quality Manual, Site Master File and Design History File.

  • SCES QMS ensures that policies, procedures and processes are in place so that all Quality Systems activities meet applicable regulations while allowing for monitoring the progress and the completion of Quality System related activities o SCES QMS The Group is actively driving continuous improvements of the Quality systems in scope.

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

  • Management and oversight of assigned Quality Management Systems. Act as SCES System Owner / Process Owner.

  • Responsible for maintaining oversight over system health and performance. Additionally, identifying opportunities for continuous improvement, devising strategies to improve system performance and efficiencies. Lead implementations, including systems infrastructure modifications and enabling knowledge transfer to system users.

  • Role owner needs to establish an active Sanofi network, connecting with other applicable System Owner throughout the company and support global initiatives where needed.

KEY RESPONSIBILITIES:

  • Ensures compliance of assigned SCES’s Quality systems to applicable corporate requirements, e.g., through completing gap analysis against standards/ guidance or execution of assessments supporting the GRT/ GRIC process.

  • Participate in policy discussions and represent the Quality System team on issues impacting the direction of quality organization and alignment to the Sanofi Quality plan.

  • Ensures systems access is controlled and effectively monitored.

  • Provides regular metrics and supports trend reporting and quarterly Quality Maturity Index (QMI) assessments for assigned Quality Systems.

  • Generates and presents system health assessments for Quality Management Review, Quality Council, /Quality Maturity Index, DIMM, and other relevant governance forums.

  • Engages in multi-site forums (e.g., Community of Practice), supports the review of quality systems, identifies, and incorporates any necessary improvements to those systems.

  • Serves as key member of SCES Inspection Readiness team. Routinely evaluate regulatory inspection documents.

  • Generates, reviews and revises Procedures, Documents and Reports in scope of the SCES Quality Management Systems group and ensure SCES’s procedures are in alignment with Regulatory requirements, Sanofi Directives/ Standard.

  • Demonstrate strong leadership qualities and embody Sanofi’s core leadership principals.

  • The Quality Manager, QMS will support cross functional teams containing, e.g., members of Operation, Regulatory, Supply chain, QA, QATS, IT, Validation, Logistic, CMOs, QC and perform review and approval of complex Change Control (CCR) and CDI records and ensure strategy and decisions are clearly and appropriate justified.

  • Develops an active network with other Sanofi Sites to establish influence for local and global responsibilities. May include travel, e.g., global process improvement roll-out activities.

ADDITIONAL RESPONSIBILITIES:

  • May act as Quality Maturity Index Assessment lead for SCES

  • May act as lead for the global document remediation process for SCES

  • May facilitate the quarterly Quality Management System review and Annual Site Quality System Review.

  • May execute the role of the SCES Data Integrity and /computer LCM Champion including the following responsibilities:

  • Oversight of SCES’s Data Integrity (DI) program and the Computer Live Cycle Management (LCM) in alignment with DI Roadmap and DI charter.

  • Business Quality Representative (BQR) for computerized system/equipment projects by providing quality assurance support (including ERES assessments, periodic review, IT inspection readiness).

  • Drive IT compliance & DI culture and mindset within SCES in partnership with Global Quality, e.g. through organizing training and knowledge/ best practice sharing initiatives and keeps SCES aware of industry trends.

  • Review and approve System Lifecycle deliverables (SDLC) to ensure that procedures and methodologies are followed.

  • Reports Status and progress of DI program and computer LCM within QMR and ASQSR.

  • Owns DI Master Plan, ensures generation and timely revision, tracks action item closure.

  • Represents SCES in cross- site computerized system LCM and DI Community of Practice (CoP).

  • Prepare annual computerized systems LCM health assessment and continuous improvement roadmap.

  • Collaborate with the Digital Champion, if applicable

LEADERSHIP QUALIFICATIONS

  • May mentor less-senior peers, if applicable

BASIC QUALIFICATIONS

  • Bachelor’s degree in science or engineering with a minimum of 6 years of experience in a cGMP environment or master’s degree and a minimum of 4 years’ experience in cGMP environment.

  • Operational experience in one or more of the following areas: Quality Engineering/Quality Assurance/Quality Control/Quality Management Systems. Demonstrated knowledge of cGXP regulations and guidance. Strong experience with quality tools and process improvement techniques.

  • Strong leadership ability

PREFERRED QUALIFICATIONS

  • Experience with ISO 13485

  • Self-motivated and highly organized

  • Enjoys working in a dynamic environment

  • Excellent oral and written communication skills

  • High attention to detail and accuracy

  • Strong interpersonal skills and negotiation skills

  • Project Management skills

  • Excellent presentation skills

  • Hands on problem solving and strong analytical skills

  • Effective team player across functional departments and in a team environment

  • Strong computer skills using e.g., Phenix, Excel, Word, PowerPoint and databases

  • Special Working Conditions

  • Role may require up to 20% regional and international travel to allow collaboration within the Sanofi network, the support of other SCES location e.g. Frankfurt, (GER), Haverhill (UK) and Ghent, (Belgium) and representation of Sanofi e.g. during external conferences.

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.

#GD-SG

#LI-GZ

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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