Quality Assurance Manager

Integrated Resources, Inc ( IRI ); Salt Lake City (UT); On-site; USD 95,000 - 130,000; Full time

Job summary

Integrated Resources, Inc ( IRI ) is seeking a senior-level Compliance Specialist to support GMP quality systems, regulatory compliance, audits, inspection readiness, CAPA, investigations, and quality documentation within a pharmaceutical environment.

This independent role requires strong judgment, problem-solving, and cross-functional communication. Management experience is not required.

Qualifications

• Bachelor’s degree in a scientific/engineering discipline or equivalent experience.
• 5+ years of GMP/quality compliance experience; 7+ years preferred.
• Strong knowledge of cGMP and pharmaceutical quality systems.
• Experience with audits, FDA inspections, CAPA, investigations, and documentation review.
• Strong technical writing, communication, analytical, and problem-solving skills.
• Experience with Quality Technical Agreements preferred.

Responsibilities

• Lead/support GMP quality system compliance, audits, and inspection readiness.
• Manage CAPA, investigations, compliance issues, and corrective actions.
• Review and approve quality documentation and QTAs.
• Monitor site compliance metrics and support Quality Council activities.
• Conduct regulatory reviews, gap assessments, and knowledge management.
• Support supplier/vendor qualification and compliance programs.
• Develop/update procedures and provide technical reports to management.
• Collaborate with Quality, Operations, internal teams, and external partners on compliance initiatives.

Skills

GMP compliance

Quality systems

Regulatory knowledge

Technical writing

Problem-solving

Communication

Cross-functional collaboration

Education

Bachelor's degree in science or engineering

Tools

SAP

Oracle

LIMS

TrackWise

Veeva

QDocs

LMS

MS Office

Job description

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Position Overview

Seeking a senior-level Compliance Specialist to support GMP quality systems, regulatory compliance, audits, inspection readiness, CAPA, investigations, and quality documentation within a pharmaceutical environment. This is an independent role requiring strong judgment, problem-solving, and cross-functional communication. Management experience is not required.

Key Responsibilities

• Lead/support GMP quality system compliance, internal/external audits, and inspection readiness.
• Manage CAPA, investigations, compliance issues, and corrective action plans.
• Review and approve quality documentation and manage Quality Technical Agreements (QTAs).
• Monitor site compliance metrics and support Quality Council/Management Review activities.
• Conduct regulatory reviews, gap assessments, and knowledge management activities.
• Support supplier/vendor qualification and compliance programs.
• Develop/update procedures and provide technical reports and presentations to management.
• Collaborate with Quality, Operations, internal teams, and external partners on compliance initiatives.

Required Qualifications

• Bachelor’s degree in a scientific/engineering discipline or equivalent experience.
• 5+ years of relevant GMP/quality compliance experience; 7+ years of progressive pharmaceutical/related industry experience preferred.
• Strong knowledge of cGMP and pharmaceutical quality systems.
• Experience with internal/external audits, FDA inspections, CAPA, investigations, and documentation review.
• Strong technical writing, communication, analytical, and problem-solving skills.
• Experience with Quality Technical Agreements preferred.
• Familiarity with SAP/Oracle, LIMS, TrackWise, Veeva, QDocs, LMS, and MS Office is a plus.