Director, Quality Systems and Data Integrity

Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Purpose

Job Description

Establish, Implement, lead, and manage an effective Global GxP Data Integrity Program supporting Global Operations. Lead business ownership for Quality Operations global enterprise IT systems ensuring system applications support and manage the business effectively. Build an effective strategic business process improvement plan to ensure business processes associated with each respective enterprise system is managed to reflect a best-in-class quality operating system. The role is responsible for ensuring Quality Centers of Excellence associated with global enterprise systems and associated quality system processes are effectively operating to optimize business processes.

Responsibilities

• Lead the Data Integrity program for AbbVie Operations
• Engage with peers in the industry for baselining and ensuring best in class practices for data integrity DI standards; Assess new regulations and any changes to existing regulations in relation to data integrity.
• Oversee COEs & CoPs for processes associated with Enterprise systems for the Quality Operation: Electronic Document Management System,Data Management System,Trackwise,Empower, etc. (May need to also provide oversight to systems used in Operations without formally owning the systems/ processes.)
• Effectively manage and execute strategic business opportunities to improve business processes. Lead process improvements, new system applications and system changes across the network (internally in the global quality function and across Operationsas per the system application).
• Drive harmonization of global processes/data and local fit/gap activities to determine system vs business process change requirements.
• Provide adjunct oversight of regulatory compliance for software development and validation lifecycle activities associated with GxP computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and AbbVie business requirements.
• Lead Systems integration, as applicable and provide oversight of key GMP systems that are added in the network though integrations.
• Provide mentorship, leadership, and prioritization to staff to execute their respective duties.
  
  
  

Qualifications

• Bachelor's degree required. Preferably in IT, Computer/Data Science, Healthcare Sciences or Engineering.
• 15 years experience in GMP pharmaceutical, biologics and/or medical device manufacturing; 5 years leadership experience.
• 10 years experience in a data and systems-related role in a regulated industry
• High level of competence, confidence, and credibility for interaction with executive management.
• Skilled in the strategy development, initiation, selection, coordination and management of projects and have the ability to solve unique problems.
• In depth knowledge of regulations for Data Integrity and Risk Management, including FDA, EMA, PICs, and WHO.
• Skilled in the strategy development, initiation, selection, coordination and management of projects.
• Strong technical and analytical skills with an ability to solve unique technical events across multiple enterprise systems applications.
• Understanding of IT system and its application in the business operation. Knowledge of the business operation in which the enterprise system operates is fundamental.
• Capable to manage multiple priorities and maintain adherence to timelines.
  
  
  

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, andwemay ultimatelypay more or less than the posted range. This range may be modified in 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 to participate in our short-term incentiveprograms.
• This job is eligible to participate in 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 employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at 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, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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