Sr Quality Systems Engineer

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

Job summary

Teva Pharmaceuticals in Salt Lake City, Utah, seeks a Quality Systems Specialist to manage pharmaceutical quality systems, ensure CGMP compliance, and drive change control and document management across the site.

The role emphasizes continuous improvement, participating in inspections, and supporting regulatory compliance with cross-functional collaboration to optimize manufacturing operations.

Qualifications

• Bachelor's degree in a scientific discipline with 7+ years in the industry and 3+ years in Pharmaceutical QA.
• Experience with GMP quality systems and site audits is preferred.
• Strong collaboration with Operations, MLT, R&D and Supply Chain.

Responsibilities

• Overseeing change management activities and maintaining quality records.
• Participating in inspections/audits and supporting regulatory compliance.
• Ensuring CGMP alignment and continuous improvement of QA processes.

Skills

Quality management systems

Change control

Document management

Continuous improvement

Regulatory compliance

Education

Bachelor's degree in science (biology, chemistry or related)

Job description

Role

Quality Systems Specialist supporting pharmaceutical quality management systems at a biotech manufacturing site. Primary objectives include ensuring compliance with CGMP, facilitating change control, document management, and continuous improvement initiatives.

Responsibilities

Overseeing change management activities, managing quality records, participating in inspections/audits, and supporting regulatory compliance across manufacturing operations.

Requirements

Bachelor's degree in a scientific discipline (biology, chemistry, or related), with at least 7 years of industry experience and 3+ years in Pharmaceutical QA.

Preferred experience includes manufacturing of dosage forms, health authority inspections (FDA, EMA), and project management skills.

High-Value

GMP compliance, change control, document management, pharmaceutical manufacturing, site audits, and cross-functional collaboration with Operations, MLT, R&D, and Supply Chain.

Work setup

On-site at Salt Lake City, UT; physical activity includes sitting, light lifting, and PPE use in production areas.