# Operational Quality Lead

**Company**: GSK
**Location**: Zebulon, North Carolina
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---North-Carolina---Zebulon/OQ-Team-Lead--Quality-Oversight-_443238?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_e2722bd1-e82

## Description

You will lead a small Operational Quality team that provides quality oversight across manufacturing. You will work closely with manufacturing and supply chain colleagues to protect product quality and patient safety.

Responsibilities:

- Lead and coach the Operational Quality team to deliver consistent oversight of the Quality Management System.

- Monitor quality performance using metrics and trends, escalate risk, and collaborate on corrective action plans.

- Oversee investigations of deviations, non-conformances and complaint-related issues and drive robust root cause analysis.

- Support product introductions, transfers and changes, prepare for and support audits and inspections, and coach internal teams and external partners on inspection readiness.

- Provide oversight, support, and accurate scheduling of activities to the quality team responsible for quality oversight of all GMP areas.

- Maintain presence across areas of responsibility and be the first line of contact to support initial management of quality issues.

- Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time.

- Perform a spot-check of activities across defined GMP areas to ensure compliance with quality standards.

- Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support continuous improvement efforts.

- Review GMP documentation and records ensuring Good Documentation Practice (GDP) is being maintained.

- Check that facilities are being maintained in a good state in line with local housekeeping standards.

- Track and trend quality oversight observations on collected data and facilitate mitigation actions.

Basic Qualifications:

- Bachelor’s degree in science, pharmacy, engineering, or a related discipline, or equivalent pharmaceutical industry experience.

- 6+ years of manufacturing experience from pharmaceutical industry, biologics manufacturing, distribution, supplier quality, or quality operations.

- Experience with quality systems such as deviations, CAPA, change control, and document control.

- Experience with data trending, statistical analysis, and root cause analysis tools.

- Proven experience and strong knowledge of the application of the principles of Quality Management Systems (QMS).

- Strong written and verbal communication skills for cross-functional collaboration and supplier engagement.

Preferred Qualifications:

- Leading or supervising a quality team in operations or supplier quality.

- Working knowledge of Good Manufacturing Practices and applicable U.S. regulatory expectations.

- Familiarity with inspection readiness and supporting regulatory inspection responses.

## Skills

### Required
- Data Integrity
- Detail-Oriented
- Digital Fluency
- GxP Regulations
- Influencing Without Authority
- Lean Management
- Pharmaceutical Regulatory Compliance
- Problem Solving
- Quality Assurance (QA)
- Risk Awareness
- Technical Writing

### Nice to have
- Leading or supervising a quality team
- Good Manufacturing Practices
- Inspection readiness

---

Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---North-Carolina---Zebulon/OQ-Team-Lead--Quality-Oversight-_443238?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)