Quality Engineering Leader: CAPA, Audits & GMP

Teva Pharmaceuticals; Salt Lake City (UT); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

401(k) with employer match

Paid Time Off

Life and Disability Insurance

Job summary

Teva Pharmaceuticals seeks a Quality Engineering leader to plan and manage deviations, investigations, complaints, maintenance/calibration and CAPA systems, ensuring CGMP compliance in a GMP environment. The role includes audits, regulatory inspections, and collaboration across departments to drive quality improvements.

Responsibilities include leading reports, trend analysis, action plans, and overseeing partner deviations while maintaining training and safety standards.

Qualifications

• Bachelor’s degree in Science/Engineering or equivalent with 5+ years of experience.
• Experience with deviations, investigations and CAPAs.
• Knowledge of CGMP and regulatory requirements in pharma/medical devices.
• Experience with Trackwise, LIMS/Labware or similar systems preferred.
• ASQ/CQE/CQA certification preferred.

Responsibilities

• Manage deviations, investigations and CAPAs with timely resolution.
• Lead audits and participate in regulatory inspections as SME.
• Oversee CAPA effectiveness checks and action plans.
• Develop and publish NTM reports and FDA field alerts as needed.
• Coordinate with partners and internal teams to ensure quality systems compliance.
• Regulatory compliance training and safe, efficient work practices.

Skills

MS Office

LMS

ERP

Quality systems

Project management

Communication skills

Leadership

Education

Bachelor's Degree in Science/Engineering

ASQ/CQE/CQA Certification

Tools

Trackwise

LIMS/Labware

Learning Management Systems

Statistical software

Job description

Teva Pharmaceuticals seeks a Quality Engineering leader to plan and manage deviations, investigations, complaints, maintenance/calibration and CAPA systems, ensuring CGMP compliance in a GMP environment. The role includes audits, regulatory inspections, and collaboration across departments to drive quality improvements.

Responsibilities include leading reports, trend analysis, action plans, and overseeing partner deviations while maintaining training and safety standards.