Operational Quality Specialist

GlaxoSmithKline; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

GlaxoSmithKline in the United States seeks an operational quality oversight professional at a manufacturing site. You will collaborate with production, laboratories, engineering and quality teams to ensure processes comply with cGxP standards, provide independent QA oversight, and maintain inspection readiness.

You will review batch records, support quality decisions, and escalate issues to protect product quality.

Qualifications

• GxP knowledge and GMP/compliance understanding.
• Experience in batch record review and QA decision-making.
• Collaborates with production, labs, engineering and QA.

Responsibilities

• Ensure GMP processes and regulatory requirements are followed, maintaining inspection readiness.
• Maintain shopfloor oversight and be the first line of contact for quality issues and escalations.
• Perform cGMP documentation reviews to ensure data integrity and GDP compliance.
• Review and final approve batch records and related documentation.

Job description

Business Introduction

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

You will provide operational quality oversight at a United States manufacturing site. You will work closely with production, laboratories, engineering and quality teams to keep processes compliant, safe, and reliable. To ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. To improve the effectiveness of quality in preventing, identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. To maintain presence and be accountable for batch record review and approval, key quality decision-making, and quality escalations. To be a liaison between operations and the site QA Systems, QA Compliance and QA Product Release (QAPR) departments. We value practical problem solvers who make clear decisions and coach others. This role offers hands‑on learning, visible impact on product quality, and growth opportunities that align with our mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities

Ensure that all GMP processes and operational personnel adhere to current GMP, applicable regulatory requirements, and procedures, minimizing risk of non‑compliance and maintaining inspection readiness at all times. Maintain shopfloor oversight across area of responsibility and be the first line of contact to support initial management of quality issues, demonstrate quality decision‑making, and provide quality escalations as needed. Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real‑time, allowing for timely interventions to prevent deviations and defects. Perform a spot‑check of activities across production and laboratory areas to ensure compliance with quality standards that includes production, testing, cleaning and maintenance activities. Carry out review of cGMP documentation and records ensuring that the content meets defined criteria, exceptions have been appropriately addressed, and Good Documentation Practice (GDP) is being maintained following ALCOA+ principles for data integrity, audit and traceability. Review and final approve batch records and batch related documentation. Provide review, initial impact approval, and final