GxP Quality Release Lead

GlaxoSmithKline; Zebulon (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Onsite cafeteria

Onsite gym

Temperature-controlled environment

Health & Wellness clinic onsite

Job summary

GlaxoSmithKline Zebulon site seeks a quality professional to provide operational quality support across GMP areas including OSD, MDI and MDPI. You will review release documentation, ensure GDP data integrity and escalate quality issues to protect patient safety.

You will lead CAPA activities, perform real-time quality oversight, and collaborate with manufacturing and quality teams to prevent deviations. The role is on-site in Zebulon, NC with opportunities to influence continuous improvement.

Qualifications

• Bachelor's Degree and 4+ years GMP pharmaceutical experience.
• 4+ years in Pharmaceutical Manufacturing, Quality, QC or similar and applying QMS/GMP to day-to-day
• Experience with deviations, CAPA, change control, and document control.

Responsibilities

• Provide quality oversight for GMP areas including Oral Solid Dose, Metered Dose Inhaler (MDI) and Multi-Dose Powder Inhaler (MDPI), Laboratories, Warehouse, and Facility/Utility areas.
• Be first-line contact to manage quality issues and assess deviations, ensuring timely escalation when needed.
• Review and second-check batch records for compliance to cGMPs, SOPs and GDP data integrity per ALCOA++ principles.
• Provide guidance during GMP activities to detect potential quality issues and support CAPA/root cause analysis.
• Perform spot-checks across GMP areas to ensure housekeeping and deviation escalation.
• Collaborate with cross-functional teams to implement corrective/preventive actions and drive continuous improvement.
• Coach employees on procedures and the importance of quality and patient safety.
• Communicate effectively and provide on-call support as required.
• Create, review and verify CoA/CoC aligned with market requirements and GSK standards.

Skills

Quality oversight

GxP regulations

CAPA

Problem solving

Communication

Education

Bachelor's degree

Tools

MERP

Microsoft Office

Power BI

VQD

Job description

GlaxoSmithKline Zebulon site seeks a quality professional to provide operational quality support across GMP areas including OSD, MDI and MDPI. You will review release documentation, ensure GDP data integrity and escalate quality issues to protect patient safety.

You will lead CAPA activities, perform real-time quality oversight, and collaborate with manufacturing and quality teams to prevent deviations. The role is on-site in Zebulon, NC with opportunities to influence continuous improvement.