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AbbVie
Senior Manager, Combination Products & Medical Devices
Career Insights for Product Development Manager
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What they do
A Product Development Manager is responsible for developing new products by identifying potential markets or requirements, perhaps by conducting market research. Determines the product requirements, specifications, production timetables and pricing. introduction. May also develop marketing strategies.
$148,946 / year median in Illinois
-3% projected decline
Job Description
Senior Manager, Combination Products & Medical Devices Employer AbbVie Location North Chicago, IL Salary 124500 - 236500 USD Start date Jul 6, 2026 View more categories View less categories Discipline Engineering , Quality , Quality Assurance Required Education Bachelors Degree Position Type Full time Hotbed BioMidwest , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details 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 at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
InteractwithandinfluencedecisionsofvariousR DandOperationsDirectorsandexternal customers. Leadcomplexglobalcross-functionalqualitysystemprocessimprovementteams. Assureproperintegrationandsupportofdeviceregulations,drugregulationsandasappropriate, biologicsregulations. Responsible for compliance with company policies and procedures.
Workcloselywithresearchorganizationtoensurepotentialproductissuesareidentifiedandaddressedinthedesign.
Assurerobustproductvs.customerrequirements.
Ensure interfacestodrug development whereappropriate. Ensuredesigncontroldocumentation(Traceability/Linkages)&designchangecontrolrequirementsaremet.
Assessthe impactofachangeonthesafety,efficacyofthecombinationproduct/device.
Analyzeandjustifytheimpactofcumulativechanges.
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.
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. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html Company 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 at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description Purpose:
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. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html Company 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 at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.