Sr. Quality Systems Engineer

United Pharma; Utah; On-site; USD 110,000 - 150,000; Full time

Job summary

United Pharma is seeking a Senior Quality Systems Engineer to strengthen site QMS, GMP compliance, and documentation workflows. The role focuses on validation, qualification, and change management to sustain compliant manufacturing operations.

You will oversee change control processes, review quality records and SOPs, and support continuous improvement and metrics tracking to meet regulatory standards.

Qualifications

• 5+ years in Quality Systems/GMP/compliance within pharmaceutical manufacturing.
• 3+ years QA in pharmaceutical production.
• Bachelor’s degree in biology, chemistry or related field preferred, or equivalent experience.

Responsibilities

• Support and maintain QMS and GMP compliance programs.
• Lead Change Control activities from initiation to final approval.
• Host and facilitate the Change Control Review Board.

Skills

Quality Systems

GMP Compliance

Change Control

Documentation Management

Education

Biology/Chemistry degree

Job description

We are seeking a Senior Quality Systems Engineer with strong experience in Quality Systems, GMP compliance, and pharmaceutical manufacturing. This role will support and improve site Quality Management Systems (QMS), documentation management, continuous improvement, validation, qualification, and change management activities.

Key Responsibilities:

• Support and maintain Quality Management Systems (QMS) and GMP compliance programs.
• Lead and oversee Change Control activities from initiation through implementation and final approval.
• Host and facilitate the Change Control Review Board.
• Review and approve SOPs, protocols, risk assessments, quality records, and other controlled documentation.
• Support documentation and records management for compliant facility shutdown planning and execution.
• Support continuous improvement programs, site KPIs, metrics, and Quality/Compliance initiatives.
• Support process, cleaning, and computer system validation, as well as equipment, facility, and utility qualification activities.
• Support Annual Product Reviews, metrics, and data trending.
• Help ensure facility operations remain compliant with cGMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, and applicable company requirements.

Skills & Qualifications:

• Minimum 5+ years of Quality Systems / GMP / Compliance experience in pharmaceutical manufacturing.
• 3+ years of Quality Assurance experience within pharmaceutical production.
• Bachelor’s degree in Biology, Chemistry, or another scientific discipline preferred, or equivalent education/experience.
• Minimum 7 years of relevant progressive pharmaceutical industry experience preferred.
• Strong experience with Change Control and Quality Documentation Management.
• Experience reviewing and approving SOPs, protocols, risk assessments, and quality records.
• Strong technical writing, problem-solving, judgment, and decision-making skills.
• Ability to work independently and make higher-level quality/compliance decisions.
• Experience with pharmaceutical dosage-form manufacturing preferred.
• Experience supporting FDA/EMA/ANVISA or other Health Authority inspections preferred.