Quality Engineering Manager: CAPA, Audits & Deviation Lead

Teva; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Generous annual leave

401(k) with employer match

Life and disability insurance

Flexible health benefits

Job summary

Teva, a leading biopharmaceutical company in Salt Lake City, seeks a senior Quality Engineering leader to plan and manage deviations, investigations, complaints, CAPA systems, and regulatory compliance. You will oversee audits, partner relationships, and training to uphold CGMP standards.

Join a high-performing team in a role that drives quality improvements, CAPA execution, and regulatory readiness across manufacturing and QA functions.

Qualifications

• Bachelor's Degree in Science/Engineering or equivalent with a minimum of 5 years relevant progressive experience in the pharmaceutical or medical device industry.
• Experience with the handling of deviations, investigations and CAPAs.
• Experience in a GxP manufacturing environment with CGMP and regulatory requirements.
• Experience with Manufacturing/Quality systems such as Trackwise, LIMS/Labware, Learning Management Systems and statistical software preferred.
• Experience with managing partner relationships preferred.
• ASQ/CQE/CQA Certification preferred.

Responsibilities

• Manage and develop direct and indirect reports.
• Establish and maintain procedures for deviation reports, investigations and CAPAs.
• Develop CAPA and effectiveness checks with area leaders.
• Perform trend analysis and generate reports with improvement recommendations.
• Oversee maintenance and calibration activities for CGMP equipment; review EAM records.
• Publish NTM reports and FDA field alerts for significant quality events.
• Act as SME in audits and regulatory inspections.
• Complete training and maintain CGMP compliance.
• Maintain clean, safe work areas and adhere to SOPs.

Skills

People management

Deviations & CAPAs

GxP CGMP

Quality systems

Audit/Regulatory

Vendor/Partner management

Education

Bachelor's Degree in Science/Engineering

Tools

Trackwise

LIMS/Labware

Learning Management Systems

Statistical software

Job description

Teva, a leading biopharmaceutical company in Salt Lake City, seeks a senior Quality Engineering leader to plan and manage deviations, investigations, complaints, CAPA systems, and regulatory compliance. You will oversee audits, partner relationships, and training to uphold CGMP standards.

Join a high-performing team in a role that drives quality improvements, CAPA execution, and regulatory readiness across manufacturing and QA functions.