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Sanofi Group Compliance Specialist Principal in Northborough, Massachusetts

Department Description:

QA Disposition is responsible for the disposition of raw materials and finished product atSanofi's Northborough Operations Center, a state-of-the-art multi-product labeling,packaginganddistributionfacility.QADisposition'smainfunctionisasfollows:

  • Ensure cGMP's and market regulations are adhered to during finished productpackagingoperations

  • Ensure all testing and documentation for raw materials and finished product meetscriteriaper applicableMaterialSpecifications

ln support of our main function, our additional areas of responsibility include; issuing andreviewing/approval of production records and related support documents, validation studyreview/approval, SOP review/approval, finished product inspection, deviation/CAPAreview/approval, external department support activities and final disposition of finishedproductandraw materials for distribution.

Position Summary:

Key Responsibilities may differ among employees with same job title and may changeovertimeinaccordancewithbusiness needs.

Core Responsibilities:

This position is responsible for performing a variety of complex tasks workingindependently with little to no supervision and in compliance with cGMP's to support LabelandPackagingoperations andraw materialdisposition.

Responsibilities I nclude:

  • Performing finished product disposition in accordance with Sanofi SOP's, approvedproductspecifications andmarketregulations

  • Reviewing and approving validation protocols and change controlsAuthoring,revisingandreviewingSOP'sthroughGEODEsystem

  • Utilizing SAP(Comet), CatsWeb, TrackWise and Phenix to perform QA review/approval ofdeviationsandassociatedCAPAs,andproductcomplaints

  • Performing compliance walkthroughs and statistical analysis of results to process orequipmentcompliancetoFDAandGMPrequirements

  • Interpreting complex, explicit documentation for new and current procedures and FDAenforcementactions/trends

  • Completinganalysis,identifyingissuesandprovidingrecommendationsforcomplianceimprovements

  • CompletingProductcomplaintsinCatsweb,Comet(SAP)Participateinauditreadiness

  • SupportProductlaunches

  • Responsible for QA project managementDevelopmentandtrainingofnewstaffasneeded

  • ParticipateinspecializedprojectsbothwithinQualityandcross-functionally

  • Perform all aspects of Quality Disposition as it pertains to release activities that willinclude, but not limited to the disposition of raw materials and final packaging/componentlots

  • SupportadditionalareasofQualityDispositionincludingRejected,QualityHoldandNon-ConformingMaterials

  • SupportandwhenneededleadtheMaintenanceofMaterialMasterDatainERPsystem

  • EffectivelydemonstratesanunderstandingofGMPs&howitappliestospecificresponsibilities.

  • Following accurate oral & written procedures in performing QA tasksStayingup-to-dateontrainingofallprocedures

  • Routinely and safely handle high value product vials in various stages of packagingcompletion

  • Monitoring operations to ensure compliance with process specificationsAdheringtoSanofi'ssafetyproceduresandguidelines

  • Participate in the QA consistency meetings to drive continuous improvement effortsParticipateininternalaudits

  • Participate and/or lead in QA audit readiness program as well as assist and participate inexternalaudits andregulatoryinspections

  • Participate in QA audit readiness program as well as assist and participate in externalauditsandregulatoryinspections

  • ParticipateormayleadinLeaninitiativestoimproveQualityprocesses

  • Effectively interact on a cross functional basis providing QA guidance at the area level andescalateanyissues toManagementinatimelyfashion

  • MayactasachangeownerforQAchangecontrols

  • MayactasthechangeownerforQAdocumentchanges

  • EnsurethatdepartmentgoalsareachievedandontimeQualityproductisrealized

  • through execution of primary role in area of oversight (Batch Record Review, DeviationManagementand/or lotdisposition,etc.)

  • ComplywiththerequirementsofSanofi’shealthandsafetyprogram

Leadership Qualifications:

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 its people and products.

  • Acting as a role model for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgement 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 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 10 years of experience in Quality and/or Operations experience in a cGMP \Manufacturing Environment or equivalent

  • Knowledge of cGMP regulations for US, EU and other markets

  • Experience with using operational excellence tools to drive continuous improvement Strong technical writing skills

  • Strong computer, verbal and written communication skills

  • Experience training and mentoring colleagues

  • Ability to prioritize and successfully manage multiple competing activities

Preferred Qualifications:

  • Bachelor's degree with 8-10 years Quality and/or Operations experience in a CGMPManufacturingEnvironmentor equivalent

  • Industry bio-pharmaceuticalexperienceQualitysubjectmatterexpert

  • Ledprojectteams

  • Leddevelopmentandtrainingandstaff

  • Performedallaspectsofthedeviation/investigationsworkflow

  • Clearcommunicator;strongverbal,writtenandtechnicalwritingskills

  • Effective time management, detail oriented, organizational skills, teamwork andcollaboration

  • Trackwise or Phenix system experiencedExperiencewithManagementInventorysystem

  • ExperiencewithQualitydatabasesystem,e.g.,CometandCatsweb

Special Working Conditions:

  • Ability to gown and gain entry to manufacturing areasMustbeabletolift50lbs

  • Requiresextendedtimeinmanufacturingareas

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.



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.