Associate Director, eQMS Technologies

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.

Job Description

Purpose

The Associate Director eQMS (electronic Quality Management System) Technologies is primarily responsible for quality system activities which include: own and support RDQA, R&D, and Enterprise quality systems and applications, support AI and other data-driven functionality, support business driven objectives, and lead project work related to quality system implementation, compliance initiatives, AI, analytical tools, and quality metrics. This position helps ensure that effective quality systems and services are in place across R&D to allow the development of high quality, safe and effective products in compliance with global regulatory requirements and applicable Policies, processes and procedures. These objectives support pharmaceuticals, biologics, combination products and medical devices reporting into the Director, eQMS Technologies.

Responsibilities

• Business system owner (BSO) of validated and more advanced or enterprise computer systems, applications, and data/AI systems
• Review and approve key technical documentation that ensure the compliance of supported systems
• Create and provide training on supported systems
• Work with business partners to ensure the adoption of new systems and continued use of established systems
• Lead and prioritize remediation efforts for any process or technical system issues
• Work and influence internal and external business partners to understand and optimize quality processes that utilize electronic quality management systems
• Develop short-term and long-term strategies that optimize current and future projects.
• Develop and implement quality metrics that demonstrate the health of supported systems
• Lead/support continuous quality improvement activities including analytical and metric tools
• Sponsor technical projects and provide strategic guidance
• Interacts with senior management to recommend technical solutions and analytics for RDQA processes.
• May manage people
  
  
  

This role is a hybrid role with onsite at our Lake County, IL Headquarters.

Qualifications

Required:

• Bachelors Degree-required in Pharmacy, Engineering, Computer Science, Business, Chemistry, Biology, Microbiology, or relevant course of study
• 8-10 years of experience in engineering, or quality systems, or business support in a regulated environment.
  
  
  

Preferred

• Experience implementing computerized QA Systems and/or metric or analytical tools
• Knowledge of tools and techniques that can be leveraged into actionable activities
• Knowledge of Risk Management principles to help organization focus on the most impactful activities
• Quality Systems knowledge and related experience
• Knowledge of the clinical development for pharmaceuticals and/or medical devices.
  
  
  

Travel: Yes, 10 % of the Time

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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://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