Operational Quality Specialist - MES

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

Benefits offered by this job

Health benefits

Job summary

GlaxoSmithKline is seeking a Quality Assurance professional to oversee MES workflows and electronic batch records, ensuring GMP compliance and data integrity across manufacturing processes.

You will review changes to master data, validate documentation, and coach operations toward continuous improvement while collaborating with manufacturing, IT, and quality teams.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 3+ years’ experience in a regulated QA environment.
• Must have MES implementation experience.
• Understanding of pharmaceutical facilities and systems.
• Knowledge of GMP, FDA/NIH regulations and validation principles.
• DMAIC root cause analysis training/experience.
• Experience with GMP and Good Documentation Practices.

Responsibilities

• Provide operational QA oversight for MES workflows and electronic batch records.
• Ensure GMP compliance and inspection readiness across processes.
• Review changes impacting Master Data and URS/PI documents.
• Approve validation and data-related documents with SAP/OsiPi integration.
• Coach teams on data integrity and procedures in a Quality Starts With Me culture.
• Lead investigations for deviations and CAPA with root cause analysis.
• Support audits and regulatory inquiries related to computerized systems.
• Monitor MES quality KPIs and drive continuous improvement.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

Bachelor’s degree in Life Sciences

Tools

SAP

OsiPi

LIMS

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 is 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

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. Directly support Operational through development, review, and approval of MES related design, implementation and performance management tasks. You will provide operational quality assurance for Manufacturing Execution System activities that support drug product manufacturing. You will work closely with manufacturing, engineering, IT, and quality teams to keep processes compliant and data trustworthy. We value clear decision makers who coach others and act with integrity. This role offers hands-on learning, visible impact, and clear career growth aligned with our mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities

• Provide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.
• Ensure that all GMP processes and operational personnel adhere to current GMP, validation, quality, safety and environmental regulations are met maintaining inspection readiness at all times.
• Review eCC, TCD and/or other QS change for impact to: Master Data (Equipment, sMBR, Workstations, Workcenters).
• Main-PI, Sub-PI design/validation Review and approve creation and/or updates to master data: Equipment Spec File (as QA Master Data) sMBR (as sMBR QA Reviewer) including integration with SAP and OsiPi Review and approve creation and/or updates to URS and Design of Main-PI, Sub-PI (as QA PI Reviewer and QA Ops, as applicable) Including integration with SAP and OsiPi Approval of Validation Form for Main-PI, Sub-PI pre and post-execution (as QA PI Reviewer) including applicable incident management and including integration with SAP and OsiPi GxP, DI, Business Continuity Risk Assessments, PI inventory IO/PQ protocol and report, including applicable validation impact assessment/unplanned events (as QA PI Reviewer and QA Ops, as applicable).
• Audit Trail Reviews Develop/Approve MES LSOPs and associated child documents Provide review, initial impact approval, and final approval of deviations and associated CAPA plans, logbooks, PQRs, customer complaint investigations, change controls, validation documents, etc.
• 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.
• Perform regular shopfloor and system walkthroughs to identify risks and coach teams on good documentation and data integrity.
• Lead or support investigations for deviations, system incidents, and data anomalies, including root cause analysis and CAPA follow-up.
• Review and approve change controls, validation summaries, and procedural updates that affect MES or digital records.
• Support inspection readiness, internal audits, and regulatory questions related to computerized systems and digital records.
• Monitor MES-related quality KPIs and trends and recommend process or system improvements.

Basic Qualifications

• Bachelor’s degree in Life Sciences, Biology, Chemical Engineering.
• A bachelor's degree in other disciplines may be acceptable if sufficient technical depth has been achieved from experience.
• Minimum 3 years' experience in regulated industry preferably in Quality Assurance.
• Must have prior MES implementation experience.
• Requires understanding and experience with pharmaceutical facility, equipment and systems.
• Including technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
• Experienced with GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficient to apply to quality operations and compliance, with knowledge of validation principles, aseptic processing, quality systems and FDA regulations.
• Training and work experience in DMAIC root cause analysis methodology.
• Must have 1 + year of hands-on experience with Good Manufacturing Practices and Good Documentation Practices.

Preferred Qualifications

• Experience in biologics manufacturing preferred.
• Familiarity with electronic records guidance such as 21 CFR Part 11 or Annex 11.
• Hands-on experience supporting system validation (IQ/OQ/PQ) or computerized system lifecycle tasks.
• Experience with LIMS, electronic batch records, or other digital manufacturing solutions.
• raining 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.
• Training or experience in root cause analysis and CAPA methodologies.
• Demonstrated ability to influence cross-functional teams and coach colleagues on quality and data practices.

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Technical Writing

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

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

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.

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.