Operational Quality Specialist
Listed on 2026-09-12
-
Quality Assurance - QA/QC
Production QC/QA, Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
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.
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.
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.
- 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…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).