Quality Systems Leader — Change Control & CGMP

Tevapharm; Salt Lake City (UT); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) with company match

Vacation and PTO

Job summary

Teva Pharmaceuticals in Salt Lake City seeks a Quality Systems leader to manage documentation, change control, annual product review, and quality metrics to ensure CGMP compliance. You will collaborate with Operations, MST, R&D, Supply Chain and Quality Control to drive improvements while mentoring a team and ensuring training and inspections readiness.

Strong background in QA within pharma production and experience with FDA/EMA inspections are highly valued.

Qualifications

• Bachelor’s Degree in a scientific discipline or equivalent with 7+ years in pharma quality.
• Minimum 3 years’ experience in Quality Assurance in pharmaceutical production.
• Experience with Health Authority inspections (FDA/EMA).
• Project management and advanced presentation skills preferred.

Responsibilities

• Oversee quality management system activities including documentation management and CGMP compliance.
• Lead Change Control Review Board and change control activities from initiation to approval.
• Provide records management and change control expertise for shutdown planning and execution.
• Ensure efficient facility operations in line with regulatory requirements (GMP, FDA, EMA, etc.).
• Participate in partner, internal and regulatory inspections and audits as needed.
• Review and approve SOPs, risk assessments and other quality records.
• Improve and maintain quality systems and drive cross-functional site initiatives.
• Complete training requirements and maintain compliance with assignments.
• Maintain safe, clean work areas in accordance with CGMP and SOPs.
• Support training and mentoring of staff and cross-functional collaboration.

Skills

MS Office proficiency

LMS

EDMS

ERP systems

Quality systems (Trackwise, Veeva)

Self-directed

leadership/mentoring

communication

problem solving

data analysis

Education

Bachelor’s Degree in science (biology/chemistry)

7+ years in pharmaceutical quality

3+ years QA in pharmaceutical production

Tools

MS Office

LMS

EDMS

ERP systems

Trackwise

Veeva

Job description

Teva Pharmaceuticals in Salt Lake City seeks a Quality Systems leader to manage documentation, change control, annual product review, and quality metrics to ensure CGMP compliance. You will collaborate with Operations, MST, R&D, Supply Chain and Quality Control to drive improvements while mentoring a team and ensuring training and inspections readiness.

Strong background in QA within pharma production and experience with FDA/EMA inspections are highly valued.