Global Quality Assurance Leader

4 days ago


Lake Forest, Illinois, United States Abbott Laboratories Full time
About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

Job Overview

The Sr. Manager - Global Software Quality position plays a critical role in ensuring compliance with global quality and documentation standards while driving continuous improvement activities. This role requires strong leadership skills, project management expertise, and a deep understanding of software development and validation processes.

Responsibilities
  • Ensure Compliance: Develop and maintain IT policies and procedures to ensure adherence to global quality and documentation standards, as well as compliance with regulations such as 21 CFR Part 11.
  • Analyze and Solve Problems: Conduct trend analysis to identify and fix systemic issues, working closely with stakeholders to resolve complex problems.
  • Oversee IT Systems: Manage software and IT systems, including development and change control processes for applications and infrastructure.
  • Lead Improvements: Drive continuous improvement activities using project management skills and lead software validation and quality assurance efforts.
Requirements
  • Bachelor's Degree: In Engineering, preferably Manufacturing or Mechanical Engineering.
  • Work Experience: At least 7 years of related work experience in IT or SW Validation in a quality and regulated environment.
  • International Travel: Up to 10% travel to locations such as the UK, Scandinavia, and other countries.
Preferred Qualifications
  • Regulatory Expertise: Experience with regulatory CAPA, training, documentation, validation, 21 CFR Part 11, supplier management, audit, and management reporting requirements.
  • IT Systems: Hands-on experience with IT systems and development and change control processes, including applications and infrastructure processes and controls.
  • Leadership: Proven ability to lead compliance with regulations and industry standards (21 FDA CFR Part 820, ISO 13485, and ISO 14971) in a highly regulated software development/validation environment.
Salary

The estimated salary for this position is $125,300.00 – $250,700.00 per year, depending on location and qualifications.



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