Quality Compliance Specialist

Location: Fully on‑site in Salt Lake City, UT

Schedule: Monday – Friday, 8:00 a.m. – 5:00 p.m.

Assignment Duration: Two years (Temp‑to‑Perm: No). Local candidates only.

Position Summary

This role is responsible for Quality Compliance Oversight, Quality Council Management Review, Site Compliance Metrics, Knowledge Management, Site Inspection Readiness program, Internal Audit program, Partner Management activities, and Supplier Qualification and Vendor Management program. The incumbent develops and monitors corrective action plans related to trends identified from inspection and audit observations.

Core Essential Skills

• Minimum 5 years of experience with a Bachelor’s degree (preferably scientific or engineering) or equivalent education/experience in the pharmaceutical or related industry.
• GMP Quality Systems and Regulatory Compliance experience.
• Internal & external auditing and inspection readiness.
• CAPA, investigations, and compliance issue resolution.
• Quality documentation review and Quality Technical Agreements.
• Independent problem‑solving, sound judgment, and cross‑functional communication.
• Senior‑level, independent, motivated; comfortable making higher‑level decisions.
• Experience with compliance or quality systems, documentation review/approval, and strong technical writing skills.
• Management experience is not required.

Essential Areas of Responsibility

• Prepare and support communication of site quality system status through management review forums.
• Manage Quality Technical Agreements (QTA) with internal and external partners to ensure compliance.
• Lead and execute internal audits to verify adherence to pharmaceutical manufacturing regulations.
• Coordinate and manage external audits/inspections, including timely responses and CAPA tracking.
• Oversee Inspection Readiness program to maintain site preparedness.
• Collaborate with Site Operations and Quality Management to resolve compliance issues promptly.
• Conduct Knowledge Management activities, including regulatory review and gap assessments.
• Support investigation reviews and corrective action plans, ensuring proper documentation and notification.
• Manage vendor/supplier qualification and related compliance activities.
• Ensure periodic document reviews and gap assessments for department and site compliance.
• Own and update procedures for assigned responsibilities.
• Lead special cross‑functional projects and present findings to senior management.
• Complete required training and maintain compliance with all assignments.
• Maintain work areas and perform duties safely and efficiently in accordance with company policies, cGMPs, SOPs, and Batch Records.
• Perform additional related duties as assigned.

Position Requirements

• Bachelor’s degree, preferably in a scientific or engineering discipline, or equivalent education/experience with a minimum of 5 years relevant progressive experience in the pharmaceutical or related industry.
• Strongly prefer a minimum of 3 years performing audits and measurements of GMP Quality Systems, preferably in the pharmaceutical industry.
• Experience and knowledge of cGMP and other applicable industry regulatory requirements as they relate to pharmaceutical production and associated quality systems.
• Working knowledge of FDA, EMA, DEA, EPA and other regulatory requirements for research and commercial environments.
• Experience providing support for regulatory agency inspections (preferred).
• Experience writing and negotiating Quality Technical Agreements (preferred).
• Experience in a pharmaceutical manufacturing environment (preferred).
• ASQ CQE/CQA certification (or equivalent) is preferred.

Skills, Knowledge, and Abilities

• Computer proficiency with comprehensive working knowledge of MS Office, Learning Management Systems (LMS), ERP systems such as SAP or Oracle, and manufacturing/quality systems such as LIMS, TrackWise, Veeva, and Qdocs.
• Ability to manage multiple priorities and reporting requirements.
• Ability to motivate and influence others with and/or without direct supervisory authority.
• Excellent written and oral communication skills.
• Ability to interact positively and collaborate with co‑workers, management, and internal/external partners.
• Detail‑oriented with ability to analyze information, develop possible solutions, create metrics, and articulate the link to business needs/objectives.
• Project management and advanced presentation skills.
• Self‑directed with ability to organize and prioritize work.