Quality Unit Business Process Specialist - Drug Substance

GlaxoSmithKline; Marietta (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

GlaxoSmithKline is seeking a Quality Unit Business Process Specialist to support drug substance operations at a U.S. site. You will partner with manufacturing, quality, IT, and engineering to ensure compliant, efficient quality processes and master data management.

The role emphasizes quality systems oversight, process improvement, and coaching teams to uphold high standards, with clear impact on product quality and regulatory readiness.

Qualifications

• Bachelor's degree in life sciences, engineering, quality, or related technical field.
• Minimum 3 years' experience in cGMP production, quality control, or quality assurance in a regulated life sciences environment.
• Experience designing, implementing, or supporting quality business processes, preferably involving SAP or similar ERP.

Responsibilities

• Provide quality oversight for drug substance-related business processes and systems, ensuring compliance with regulations and internal standards. Act as a key quality contact for cross-functional teams and sites on master data, process changes, and procedural questions. Develop, review, and maintain quality unit business process documentation and SOPs.

Skills

Quality oversight

GxP Regulations

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree in life sciences or related field

Tools

SAP

LIMS

MES

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 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

Join us as a Quality Unit Business Process Specialist supporting drug substance operations at a United States site. You will collaborate daily with manufacturing, quality, IT, and engineering teams to ensure quality processes run smoothly and compliantly. Your role will focus on overseeing quality systems, identifying improvement opportunities, and coaching colleagues to maintain high standards. We value practical problem-solvers who know how to communicate clearly and take ownership. This role offers visible impact, continuous learning, and career growth as you contribute to our mission of uniting science, technology, and talent to get ahead of disease together.

Responsibilities

• Provide quality oversight for drug substance-related business processes and systems, ensuring compliance with regulations and internal standards. Act as a key quality contact for cross-functional teams and sites on master data, process changes, and procedural questions. Develop, review, and maintain quality unit business process documentation and standard operating procedures (SOPs).
• Support investigations, root cause analysis, and corrective and preventive actions related to quality deviations and process issues.
• Facilitate quality impact assessments and risk reviews for process and system changes. Train and coach site colleagues on quality processes, documentation practices, and compliance requirements.

Basic Qualifications

• Bachelor's degree in life sciences, engineering, quality, or a related technical field. Minimum 3 years' experience in cGMP production, quality control, or quality assurance in a regulated life sciences environment. Experience designing, implementing, or supporting quality business processes, preferably involving SAP or similar ERP.
• Practical knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory compliance. Experience participating in change control, CAPA, deviations, or quality investigations. Strong verbal and written communication skills and ability to work collaboratively on-site with cross-functional teams.

Preferred Qualifications

• Experience in pharmaceutical or biologics manufacturing environments, particularly with computerized manufacturing systems. Familiarity with laboratory information management systems (LIMS), Manufacturing Execution Systems (MES), or electronic batch records.
• Formal training or experience in structured root cause analysis and risk assessment techniques. Proven ability to influence and coach colleagues at different levels and from multiple disciplines. Experience maintaining inspection readiness and supporting regulatory audits. Demonstrated focus on continuous improvement through monitoring of quality metrics and KPIs.

Work Arrangement

This role is on-site at a United States manufacturing location with regular presence required in production and laboratory areas. Hybrid or remote work is not available.

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

Why GSK?

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

About GSK

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.

Accommodation

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail]

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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