# Quality Assurance Lead, US Remote Based

**Company**: Fortrea
**Location**: Durham
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Salary**: USD $70,000-$125,000
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Durham/Quality-Assurance-Lead--US-Remote-Based_266337-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_147b4159-c31

## Description

We are seeking a Quality Assurance Lead to join our team and make an impact on quality across our clinical research operations. As a Quality Assurance Lead, you will serve as a quality partner to operational teams, providing guidance on quality issue management, quality risk identification, escalation requirements, and continuous improvement opportunities.

**Key Responsibilities:**

- Provide guidance on quality issue management, quality risk identification, escalation requirements, and continuous improvement opportunities to operational teams.

- Partner with internal stakeholders to facilitate the progression and resolution of quality issues within the Quality Management System (QMS).

- Monitor and drive timely progression of quality issues while identifying and escalating risks that may impact compliance, quality, or client commitments.

- Collaborate with functional teams to develop, implement, and monitor Corrective and Preventive Actions (CAPAs) to support sustainable issue resolution.

- Maintain a strong working knowledge of quality systems, processes, and regulatory requirements to support effective quality issue management.

- Partner with Quality Lead Managers and senior quality leadership to support quality issue progression, escalation activities, and client communications as required.

- Analyze quality metrics and trends to identify systemic quality concerns, emerging risks, and opportunities for continuous improvement, supporting risk-based decision making.

- Support preparation of quality summaries, trend analyses, and quality-related communications for internal stakeholders and clients, where applicable.

- Contribute to process improvement initiatives that strengthen compliance, quality oversight, and operational effectiveness.

**Requirements:**

- 5 years of experience in a regulatory environment, including experience in GxP roles.

- Strong understanding of QMS and the CAPA process.

- Knowledge of GCP and GxP requirements.

- Ability to convey key details of quality issues internally.

- Ability to communicate quality issue summaries to clients, where applicable.

- A bachelor’s degree in Life Sciences preferred, or equivalent Life Science experience.

**Work Environment:**

- Work is performed in an office environment with exposure to electrical office equipment.

- Occasional drives to site locations with occasional travel both domestic and international.

**Physical Requirements:**

- Frequently stationary for 6-8 hours per day.

- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

- Regular and consistent attendance.

- Varied hours may be required.

**Salary and Benefits:**

- Pay Range: USD $70,000-$125,000

- Comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.

## Skills

### Required
- QMS
- CAPA
- GxP
- GCP
- Life Sciences

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Durham/Quality-Assurance-Lead--US-Remote-Based_266337-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)