Senior Product Quality Leader – Pharma & Devices

BioSpace; North Chicago (IL); Vor Ort; USD 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Paid time off

Medical/dental/vision insurance

401(k)

Zusammenfassung

AbbVie is seeking a Quality Assurance professional to lead the quality and compliance efforts for pharmaceutical products, including biologics and devices, across AbbVie plants and TPM sites. The role emphasizes final product release, regulatory interactions, and strategic QA initiatives.

The ideal candidate has 8+ years in QA-related roles, strong analytical and leadership skills, and experience with FDA inspections and third-party manufacturing relationships. A life sciences degree is required.

Qualifikationen

• Bachelor’s degree in life science or related field; technical background for problem resolution.
• 8+ years experience in total; 3+ years QA Operations Management; 5+ years in Operations, R&D, Regulatory or Consulting.
• Direct manufacturing plant experience in a pharmaceutical setting preferred.
• Experience with FDA and other regulatory agency interactions and inspections.
• Familiarity with third party external manufacturing and quality systems.

Aufgaben

• Maintains the primary quality lead with management oversight for project activities and team members.
• Drives quality and compliance aspects of product transfers and organization optimization.
• Develops global Product Quality Assurance strategy for pharmaceuticals, biologics, devices and TPM facilities.
• Performs final quality release of manufactured product lots by Third Party Manufacturers.
• Makes recommendations on product quality and regulatory conformance; escalates high-risk events to management.
• Maintains relationships with Third Party Manufacturers, AbbVie plants, affiliates and other groups to address quality concerns.

Kenntnisse

Quality Assurance

Regulatory affairs

Problem solving

Leadership

Analytical thinking

Ausbildung

Bachelor’s Degree in Life Science

Jobbeschreibung

AbbVie is seeking a Quality Assurance professional to lead the quality and compliance efforts for pharmaceutical products, including biologics and devices, across AbbVie plants and TPM sites. The role emphasizes final product release, regulatory interactions, and strategic QA initiatives.

The ideal candidate has 8+ years in QA-related roles, strong analytical and leadership skills, and experience with FDA inspections and third-party manufacturing relationships. A life sciences degree is required.