Senior Quality Systems Engineer

Collabera; Salt Lake City (UT); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term disability insurance

Short-term disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Paid vacation time

Paid parental leave

Paid holidays annually

Job summary

Collabera seeks a Senior Quality Systems Engineer to support quality management in a pharmaceutical manufacturing setting, emphasizing GMP compliance, Change Control, documentation, validation, and continuous improvement.

This role oversees quality system activities, reviews and approves controlled documentation, supports audits and inspections, and collaborates across manufacturing and technical functions.

Qualifications

• Bachelor's degree in biology, chemistry, or related field, or equivalent experience.
• Minimum five years in Quality Systems and GMP/compliance in pharma manufacturing.
• Experience with change control and quality documentation management.
• Experience reviewing and approving SOPs, protocols, risk assessments and records.
• Quality Assurance experience in pharmaceutical production.
• Strong knowledge of current Good Manufacturing Practices and pharma QA systems.
• Strong technical writing and cross-functional communication.
• Proficient with Microsoft Office and electronic QMS.

Responsibilities

• Support and maintain Quality Management Systems and site quality programs.
• Lead Change Control from initiation through implementation and approval.
• Provide records management and Change Control expertise for compliant site activities.
• Review and approve SOPs, protocols, risk assessments and quality records.
• Maintain quality systems compliant with cGMP and regulatory requirements.
• Support validation activities and equipment, facility, and utility qualification.
• Support Annual Product Review, quality metrics, data trending, and continuous improvement.
• Participate in internal, partner, and regulatory inspections and audits as required.
• Collaborate on site quality projects and cross-functional quality initiatives.
• Work with Operations, MS&T, R&D, Supply Chain, and QC teams.
• Analyze complex quality issues and apply independent judgment to actions.

Skills

GMP compliance

Change Control

Documentation management

SOP reviews

Quality Assurance

Cross-functional communication

Technical writing

Microsoft Office

Electronic QMS

Education

Bachelor’s degree in a scientific discipline

Tools

TrackWise

Veeva

Learning Management Systems

Electronic Document Management Systems

ERP systems

Job description

The Senior Quality Systems Engineer will support quality management systems within a pharmaceutical manufacturing environment, with emphasis on GMP compliance, Change Control, quality documentation, validation, and continuous improvement. This position will oversee quality system activities, review and approve controlled documentation, support audits and inspections, and collaborate across manufacturing and technical functions.

Key Responsibilities:

• Support and maintain Quality Management Systems and site Quality and Compliance programs.
• Lead Change Control activities from initiation through implementation, review, and approval.
• Provide records management and Change Control expertise supporting compliant site activities.
• Review and approve SOPs, protocols, risk assessments, and other quality records.
• Maintain quality systems in compliance with current Good Manufacturing Practices and applicable regulatory requirements.
• Support process and cleaning validation, computer system validation, and equipment, facility, and utility qualification activities.
• Support Annual Product Review, quality metrics, data trending, and continuous improvement initiatives.
• Participate in internal, partner, and regulatory inspections and audits as required.
• Support site quality projects, corporate standard assessments, and cross-functional quality initiatives.
• Collaborate with Operations, Manufacturing Science and Technology, Research and Development, Supply Chain, and Quality Control teams.
• Analyze complex quality issues and apply independent judgment and problem-solving to determine appropriate actions.

Required Qualifications:

• Bachelor’s degree, preferably in a scientific discipline such as Biology, Chemistry, or a closely related field, or equivalent education and experience.
• Minimum five years of relevant Quality Systems and GMP/Compliance experience within a pharmaceutical manufacturing environment.
• Strong experience with Change Control and quality documentation management.
• Experience reviewing and approving SOPs, protocols, risk assessments, and quality records.
• Quality Assurance experience within pharmaceutical production.
• Strong knowledge of current Good Manufacturing Practices and pharmaceutical quality systems.
• Strong technical writing, documentation, and cross-functional communication skills.
• Ability to work independently, exercise sound judgment, and make higher-level quality decisions.
• Proficiency with Microsoft Office and electronic quality/document management systems.

Preferred Qualifications:

• Seven or more years of progressive pharmaceutical industry experience.
• Direct experience with pharmaceutical manufacturing and various dosage forms.
• Experience supporting Health Authority inspections.
• Experience with TrackWise, Veeva, Learning Management Systems, Electronic Document Management Systems, and Enterprise Resource Planning systems.
• Project management and advanced presentation skills.
• Experience with quality metrics, data trending, and continuous improvement.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.