Senior Product Quality Manager (Peptide Technology)

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.

Responsible for quality of assignednew product introductionprogramsto ensure business objectives are met with regards to on timedeliverables of program developmentwhile assuring compliancewithlocal, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API),andDrug Products produced by AbbVie plants or by third-party manufacturers,in Licensing relationships, or Co-Marketing relationships. Develop inconcertwiththe appropriate regulatory strategiesset forth bythe governance processes.

AbbVieOperations Quality Assuranceis seeking aProduct QualityManagertolead qualitydeliverables forlate-stage development and commercialization of Peptides, from registration through commercialization. We are seeking a highly motivated candidate with a proven track record of accomplishment in the field of peptide manufacturing development, to work in a multi-functional team environment at our North Chicago, IL location.

• Leads the developmentand implementationof global Product Quality Assurance strategy to supportNew Product Introduction (NPI) programs for the end-to-end commercial supply chain bothat AbbVie plants as well ascontract manufacturingfacilities.Drives implementation of the Product Transfer Process.Primary driver forproductquality risk management and compliance aspects of productdevelopment.

• Acts as global qualityleadto supportregulatorysubmissionby developing, reviewing and approving relevantmodule 3 documents. Workswith RegulatoryAffairs and coordinates with GMP manufacturing sitesto prepare submissions andprovides responses to agencysubmission deficiencies/questionsin a timely manner.Leads and manages pre-approval inspection readinessfor the NPI programs.Ensuresregulatory approvals are obtained with no delays to market entries.

• Leads the selection ofexternalmanufacturing partners from Quality for NPI programs. Leads the quality partner assessment and up skilling of the partners to meet AbbVie Operations expectation. Partners withQuality Assurance audit team toqualifyexternalmanufacturing partners.

• Communicates and negotiates with externalmanufacturing partnerquality organizationto maintain a consistent level of quality.Provides quality oversight to maintain partner qualification for development and commercialization.

• Supports the management of exception documents and Corrective and Preventive Actions. Coordinates input from technical groups to determine root cause and implement appropriate actions.Serves as global quality representative at the change review board todrive/supportglobal change plans needed for NPI programs.

• Establishes and maintains relationships and open communication withcrossfunctional groups to maintain roles and responsibilities and providesguidance on quality concerns.Drives continuousimprovement for NPI programs.

• Bachelors Degree in relevantSciencefieldrequired.Total combined years of experience.Minimum 8+ years. At least 3 years in Quality Assurance Operations Management; 5+ years in any of the following areas:Operations, Research and Development, Regulatory. Direct Manufacturing Plant experience in apharmaceutical setting is preferred.

• Comprehensive understandingofpharmaceutical technologies, specifically peptide technologyisrequired.Experience in pharmaceutical development and commercialization is preferred.

• Strong quality assurance/controlbackground is required. Experience with FDA and other regulatory agency interactions and inspections is required.

• Interactswell with diverse groups within function andmaintainsstrong working relationships with internal and external collaborators.

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 thisposting 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 anduntil 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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