Operational Quality Specialist

About this role

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 approval of deviations and associated CAPA plans. Provide review and approval of documentation which may include procedural revisions, logbooks, PQRs, customer complaint investigations, change controls, validation documents, etc.

• Ensure all GMPs, validation, quality, safety and environmental regulations are met. Adhere to all safety guidelines and procedures.

• Role model by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety.

• Provide on-the-floor quality oversight, perform regular shopfloor walk-throughs, and detect early quality risks. Review executed and master batch records, deviations, and CAPA plans for completeness and compliance.

• Make or recommend disposition decisions and support lot release activities following defined procedures. Support and perform self-inspections, internal audits, and inspection readiness activities.

• Review and approve GMP documentation including change controls, validation summaries, and procedural updates. Investigate quality issues, support root cause analysis, and help implement corrective and preventive actions.

Why You?

This role is on-site at a United States manufacturing location and requires regular presence in production and laboratory areas. We are building a team that values collaboration, clarity, and continuous learning. We are committed to inclusion and want colleagues who help create a respectful, supportive workplace.

Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor’s degree in b iology, chemical engineering, life sciences field or a bachelor's degree in another discipline is acceptable if technical depth has been achieved from professional experience.

• 2 + years of experience in regulated industry. S trong quality assurance background. Experience in biologics manufacturing is strongly preferred . Experience working in pharmaceutical facilities, equipment, and quality systems.

• 1+ years of experience with GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficient to apply to quality operations and compliance. 

• Experience with validation principles, aseptic processing, quality systems and FDA regulations. Experience with training in DMAIC root cause analysis methodology. Experience reviewing batch records and GMP documentation.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience in biologics or pharmaceutical manufacturing environments with deviations, CAPA, change control, and validation activities. Training or experience in root cause analysis methods such a

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