Senior Quality Systems Engineer – CGMP & Change Leader

Teva Pharmaceuticals

Salt Lake City (UT)

On-site

USD 95,000 - 135,000

Full time

9 days ago
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Benefits offered by this job

Health Insurance
401(k) with employer match
Paid Time Off
Life and Disability Insurance

Job summary

Teva Pharmaceuticals in Salt Lake City seeks a Quality Systems leader to manage QMS documentation, continuous improvement, and validation across processes, ensuring CGMP compliance and successful audits. You will drive collaboration with Operations, MS&T, R&D, and Supply Chain to uphold quality standards.

The role emphasizes change management, metrics, and training to sustain a high-performing team environment. A Bachelor's in science and 7+ years QA experience are expected.

Qualifications

  • Bachelor’s Degree in a scientific discipline and at least 7 years of QA experience in pharma.
  • Experience with CGMP and regulatory inspections (FDA/EMA) is preferred.
  • Knowledge of quality systems and documentation control.

Responsibilities

  • Oversee Change Control Review Board and change control activities from initiation through approval.
  • Provide records management and change control expertise for compliant shutdown planning and execution.
  • Ensure facility operations comply with CGMP, FDA/EMA/health authority requirements and company policies.

Skills

Quality Assurance
Change Management
Leadership
Documentation Management
MS Office
Data Analytics

Education

Bachelor’s Degree in Science

Tools

Trackwise
Veeva
MS Office

Job description

Teva Pharmaceuticals in Salt Lake City seeks a Quality Systems leader to manage QMS documentation, continuous improvement, and validation across processes, ensuring CGMP compliance and successful audits. You will drive collaboration with Operations, MS&T, R&D, and Supply Chain to uphold quality standards.

The role emphasizes change management, metrics, and training to sustain a high-performing team environment. A Bachelor's in science and 7+ years QA experience are expected.

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