Senior Manager, Combination Products & Medical Devices

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Purpose

Job Description

Primaryresponsible forrepresentingQA on cross-functional combination product and medical device development teams and executingQuality System requirements to ensure products developed, manufactured,testedandprocuredand data generated are compliant with worldwide Combination Product and Medical Device Regulations.

Responsibilities

• ManageandoverseetheinterrelatedfunctionactivitiesrelatedtodesigncontrolwithR&Dfunctions,ScienceandTechnology,OperationsQA,SupplyChain,RAandotherR&DQAfunctions.InteractwithandinfluencedecisionsofvariousR&DandOperationsDirectorsandexternal customers.
• Leadcomplexglobalcross-functionalqualitysystemprocessimprovementteams.
• Assureproperintegrationandsupportofdeviceregulations,drugregulationsandasappropriate, biologicsregulations. Responsible for compliance with company policies and procedures.
• Performdesigncontrolactivities: Mentor/leadproductteam membersthroughthedesignprocessprovidingguidance.Workcloselywithresearchorganizationtoensurepotentialproductissuesareidentifiedandaddressedinthedesign.Assurerobustproductvs.customerrequirements.Ensure interfacestodrug development whereappropriate.
• Ensuredesigncontroldocumentation(Traceability/Linkages)&designchangecontrolrequirementsaremet.Assessthe impactofachangeonthesafety,efficacyofthecombinationproduct/device.Analyzeandjustifytheimpactofcumulativechanges.
• Risk Management: Global collaborationwith R&D and Commercial Operations functions toidentifyandmitigateproduct risks to develop robust combination products and medical devices.
• Perform3rdpartysuppliermanagementactivitiessuchas reviewandapprovalof3rdpartydesigncontrolactivities,assessmentofsupplierchanges,establishmentofappropriatebalancebetweeninternaloversightactionsandsuppliercontrols,provideinputtoqualityagreements,performrelationshipdevelopment,suppliersitevisits,etc.Supportsupplierauditsasrequired.PartnerwithThirdPartyVendors/Manufacturers/Laboratoriestoensurethatcombinationproducts/devicesareincompliancewithinternalandRegulatoryAgencystandards.
• Identifygapsinexistingprocessesaswellastheneedfornewprocesses.Lead cross-functional teams for solution development and implementation.
• Guideproject development as team member in global and local product development teams for Combination Products to proactivelyavoid,orappropriatelyaddress quality-related issues.
• Provideconsultation&trainingonspecificQAexpertisetointernalandcross-functionalgroups
• Support the preparation of regulatory inspections and internal audits and represent GMP QA in inspections and audits asSME.
  
  
  

Qualifications

• Bachelor'sdegreeisrequired;preferablyinsciences,engineeringorothertechnical/scientificarea.
• Minimum6 yearsofindustryexperienceinQualityAssurance,Developmentorhealthcarerelatedfield.Medicaldeviceregulationexperiencerequired.Combination Product and 3rd party supplier management experience preferred.Lessexperienceconsideredwithadvanceddegree.
• Broadunderstandingofregulationsandstandardsaffectingcombinationproductsandmedicaldevicesrequired.MusthaveleadershipskillsandhavebeenseentotakeapositiononQualityissuesandstandards,andmustbecapableofclearlyandlogicallyjustifyingsuchpositions.
• Sound technical understanding of product development (e.g., approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control.
• Well-versedinriskmanagementmethodologiesandtheirapplication.
• Keyleadershipcompetenciesandmakingdifficultdecisions,relationship-building,influencing,fosteringteamwork.Knowledgeofthebusinessandsoundjudgment.
• Able to take the initiative toidentifyand implementnew approachesto resolve problems, able to challenge scientific arguments -stronganalytical approach toidentifyproblem areas and effective solutions.
• Workindependentlyandinaglobalteamenvironment,andwithalllevels ofpersonnelwithintheorganization.
  
  
  

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.
  
  
  

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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