Sr Quality Systems Engineer

Location

SLC EAST – 577 S. Chipeta Way, Salt Lake City, UT 84108

Responsibilities

This position provides support for the Quality Management Systems (QMS), including documentation management, continuous improvement programs, process, cleaning and computer system validation, equipment, facility and utility qualification. The role oversees Change Management, Annual Product Review, and Metrics and Data Trending, ensuring adherence to quality standards, policies, and procedures while fostering a collaborative environment among internal and external stakeholders.

• Develop, support, and execute annual projects to deliver on‑site metrics, KPIs, goals, and other Quality/Compliance program initiatives.
• Host the Change Control Review Board and oversee change control activities from initiation through implementation and approval.
• Provide records management and change control expertise to support compliant shutdown planning and execution.
• Ensure efficient, uninterrupted operation of the facility in accordance with GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, and related requirements.
• Participate in partner, internal, and regulatory inspections and audits as needed.
• Review and approve standard operating procedures, protocols, risk assessments, and other quality records.
• Improve and maintain quality systems to ensure compliance with CGMPs, company policies, procedures, and governmental regulations.
• Support Quality projects for organizational goals, including corporate standard assessments, Quality project team meetings, and cross‑functional site initiatives.
• Complete all training requirements and maintain compliance with assignments.
• Maintain work areas and perform job functions safely and efficiently in accordance with company policies, Good Manufacturing Practices (CGMP), and SOPs.
• Perform additional related duties as assigned.

Qualifications

• Bachelor’s degree in a scientific discipline (biology, chemistry, or related field) or equivalent education/experience.
• Minimum of 7 years of progressive experience in the pharmaceutical industry.
• At least 3 years of Quality Assurance experience within pharmaceutical production.
• Direct experience with manufacturing of various pharmaceutical dosage forms (preferred).
• Experience with Health Authority inspections (FDA, EMA, ANVISA, etc.) (preferred).
• Project management and advanced presentation skills (preferred).

Skills and Abilities

• Proficiency with MS Office, Learning Management Systems (LMS), EDMS, ERP systems, and Quality systems such as Trackwise and Veeva.
• Self‑directed with strong organization and prioritization capabilities.
• Ability to motivate, influence, and lead others with or without direct supervisory authority.
• Effective conflict management, delivering difficult feedback, and negotiating resolutions.
• Strong collaborative relationship‑building across teams, departments, and business units.
• Sound judgment and decision‑making abilities.
• Excellent written and oral communication skills.
• Analytical skills to create metrics aligned with business objectives.
• Understanding of inter‑departmental linkages and alignment.
• Change‑driving capability: identifying improvement areas, engaging and motivating others, and managing transitions.
• Problem‑solving: independently address complex issues, evaluate contributing factors, and select appropriate methods and techniques.

Physical Requirements

• Sitting for extended periods.
• Frequent use of fingers for picking, pinching, or typing; repetitive wrist, hand, and finger motions.
• Occasional standing for extended periods at workstations or equipment.
• Walking short distances quickly and frequently.
• Lifting objects up to 25 lb.
• Close visual acuity for computer work, data analysis, and extensive reading.
• Exposure to low‑to‑moderate noise levels; occasional exposure to moving mechanical parts or equipment.
• Use of personal protective equipment (e.g., safety glasses, hearing protection, gloves) when in production areas.

Benefits

Teva offers a comprehensive benefits package designed to support health, financial security, and work‑life balance.

• Medical, dental, vision, and prescription coverage starting on the first day of employment.
• 401(k) retirement plan with employer match up to 6 % and an additional 3.75 % defined contribution.
• Paid time off including vacation, sick/safe time, caretaker time, and holidays.
• Company‑paid life and disability insurance.
• Employee Assistance Program, Employee Stock Purchase Plan, tuition assistance, and flexible spending accounts.
• Health Savings Account, Lifestyle Spending Account, and volunteer time off.
• Paid parental leave (if eligible) and family‑building benefits.
• Virtual physical therapy, accident, critical illness, and hospital indemnity insurance.
• Identity theft protection, legal plan, voluntary life insurance, and long‑term disability coverage.