Operational Quality Specialist

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 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.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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 GSK safety guidelines and procedures.

• Role model the GPS standards and foster a ‘Quality Starts with Me’ culture 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.

Why You?

We are building a team that works together to deliver high-quality products safely and reliably. This role is on-site at a US manufacturing site and requires regular presence in production and laboratory areas. You will join a team that values collaboration, clarity, and continuous learning.

Basic Qualification

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

• Bachelor’s degree in a scientific, engineering, or technical discipline; or an associate degree in a related field combined with a minimum of two years of relevant experience.

• 2+ years of experience in a regulated life sciences manufacturing or quality role.

• knowledge of Good Manufacturing Practices (GMP) and good documentation practices.

• Experience reviewing batch records and GMP documentation.

Preferred Qualification

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

• A sound knowledge of pharmaceutical facilities, equipment, and quality systems.

• Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficent to apply to quality operations and compliance.  Working knowledge of validation principles, aseptic processing, quality systems and FDA regulations.

• Training and work experience in DMAIC root cause analysis methodology.

• Well-developed interpersonal skills and decision-making capabilities with the ability to influence different levels of the Site and Quality organization. Ability to deliver clear communications (written and verbally), coaching, foster a ‘Quality Starts With Me’ culture and work with a spirit of continuous improvement.

• Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal quality solutions and implement decisions.

• Time management skills and ability to prioritize and respond to operational needs/issues within high paced environment.

• Be a team player prepared to work in and embrace a multi-skilled team-based culture.

• Strong observational skills and the ability to make timely quality decisions on the shopfloor.

• Clear written and verbal communication skills and the ability to work effectively across teams.

How to apply

If this role speaks to your skills and ambitions, we encourage you to apply. Tell us how your experience aligns with the responsibilities and qualifications. We want to hear about the work you are proud of and how you approach problem solving. Join us and help shape a quality culture that makes a real difference to patients.

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Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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