AbbVie

Quality Assurance Manager

Employer
AbbVie
Location
North Chicago, Illinois
Posted
Nov 22, 2021
Ref
2119079
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
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, YouTube and LinkedIn.

Purpose:

Responsible for maintaining a framework that ensures robust process design and control, and continuous inspection readiness. Utilize process analysis tools. Participate in the definition and creation of global processes. Interact with outsourced clinical support teams with respect to quality, process control, and remediation efforts. Responsible for timely and effective communication in regard to state of quality and processes across Data Sciences.
Communicate requirements for inspection readiness to Data Sciences teams. Manage inspection readiness activities.

Main Responsibilities:

  • Identifies, develops and implements required policies and procedures.
  • Manages quality and process control under direct supervision.
  • Liaises with Data Sciences leadership and various functional groups by giving progress reports.
  • Coordinates all activities of functional groups to ensure that tasks undertaken do not overlap, repeat or conflict.
  • Assists in creating an environment of continuous improvement and learning.
  • Ensures adequate communications at all levels and among all organization members.
  • Utilizes appropriate quality tools to promote TQM culture and ensure process robustness. Uses predefined statistical techniques throughout the organization to better view and control processes. Manages a system and processes to ensure continuous inspection readiness.
  • Utilizes cost of quality techniques to control and effectively improve process quality. Promotes six sigma techniques to improve quality of processes. Maps processes and utilizes quality tools to improve them. Develops, monitors, measures and analyzes processes within the organization.

Qualifications
  • Bachelor’s degree in business, statistics, management information systems, computer science, life sciences or equivalent is required. Master’s degree is desired.
  • Must have 6+ years of direct clinical development experience.
  • Must have strong understanding of regulatory guidelines (e.g., FDA, EMEA, PMDA, MHRA)
  • Must have deep understanding of the clinical development process.
  • Must have demonstrated effective communication skills and ability to influence without authority.
  • Global experience is desired.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.