This job has expired

You will need to login before you can apply for a job.

IT Quality Consultant

Employer
AbbVie
Location
Lake County, Illinois
Start date
Sep 29, 2022

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Consultant
Hotbed
BioMidwest, Best Places to Work
You need to sign in or create an account to save a job.

Job Details

Software Quality Assurance ensures computer system software meets requirements and is validated throughout the system's and the drug development's life cycles. The functional group will ensure high quality products and data compliant with GxP regulations, internal policy/procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11). We have a challenging opportunity for an IT Quality Consultant based in North Chicago, IL., reporting to the Senior Software Quality Assurance Manager. Key responsibilities include:
  • Author, review/audit, and approve project documentation associated with the SLC to support applicable federal and regulatory requirements
  • Review/approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate
  • Ensure recommended changes/improvements to support the Enterprise Systems are compliant to the internal and external policies, processes, and procedures
  • Establish quality system requirements for the Information Enterprise Systems
  • Provides project quality leadership for validation or SLC activities
  • Create and apply risk-based approach strategies effectively and efficiently without compromising compliance
  • Approve key project deliverables
  • Serves as expert resource with regards to the Enterprise Systems and compliance issues
  • Generate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc
  • Lead process improvement projects

  • Bachelor’s Degree with 6 years of experience in a related field such as regulated GxP environment in qualification/validation, documentation, or compliance or equivalent experience.

Key AbbVie Competencies:

  • Experience with GxP regulations, internal policy/procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11)
  • Builds strong relationships with peers and cross functionally and with partners outside of the team.
  • Learns fast, grasps the “essence” and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.

This position is part of AbbVie’s Information Security & Risk Management (ISRM) team. We are here to put our partners in a position to succeed. We do it by providing the knowledge, tools, and support they need to effectively use data and technology while also effectively managing risk.

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.


Company

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Find Us
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert