Associate Director, Design Quality Design Lifecycle Management

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.

Job Description

The Associate Director of Design Quality Design Lifecycle Management oversees the Design Lifecycle Management team responsible for combination products and medical devices. This leadership role manages the seamlessdesigntransfer of new product designs into manufacturing, directs design change management for products already on the market, and executes assurance of supply projects. The team also drives initiatives supporting geographicexpansionand other lifecycle management activities. The role ensures all assigned productsincluding on-body delivery systems, pre-filled syringes, auto-injectors, infusion pumps, tubing, pump accessories,and aesthetics medical devices such as breast implants, fillersandbody contouring devicesmeet businessobjectives, and comply with local, divisional, corporate, and global regulatory standards.

Responsibilities

• Leadmentor and developa team of quality professionals and subject matter experts (SMEs) responsible for design controls and quality management duringdesign transfer ofnew productsand ongoing lifecycle projectsfor on-market products.
• Oversee execution and fulfillment of quality requirementsfor lifecycle management of on-market products, including change control for on-market devices, execution of assurance of supply projectsand geographic expansions.
• Facilitate effective Change Control activities, including design change impact assessments and approval of relevant changes.
• Develop design control strategiesalong with the cross-functional team to verify, validate and implement on-market design changes.
• Develop, implement, and continually improve global quality assurance strategies in partnership with Regulatory Affairs, Marketing, Operations, Product Development, and other cross-functional teams.
• Make key strategic decisions regarding product quality, compliance, and regulatory matters, escalating significant risks to AbbVie leadership as needed.
• Collect, validate, and analyze qualitymetrics,present compliance status and actionable insights for local and global initiatives during management reviews.
• Partner withcross-functional teamand third-party manufacturers to maintain consistent quality standardsandminimize compliance risks.
• Support and drive continuous improvement by identifying gaps or improvement opportunities within Design History Files, risk management, processes, and policies and tracking actions to closure.
• Foster a culture of proactive quality, cross-functional collaboration, and ongoing process improvement.
  
  
  

Qualifications

• Bachelors Degree in relevant Life Science or other technical required. Graduate degree desired. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• Total combined years of experience. Minimum of 10 in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors. Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred.
• Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, team members and individuals.
• Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required.
• A wide range of activities are undertaken from long term strategy development to short term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
• Experience working the requirements for third party external manufacturing.
  
  
  

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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