Quality Unit Business Process Specialist

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

Job summary

GlaxoSmithKline (GSK) in the United States is seeking a Quality Unit Business Process Specialist to provide QA oversight of SAP processes, drive improvements, and partner with operations, engineering, IT and quality teams to design, implement and sustain quality processes ensuring compliant and reliable production.

The role requires a strong background in cGMP, SAP systems, and change control, with the ability to translate business needs into documented processes and support continuous

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, or a related technical field.
• 3-5 years’ experience in cGMP production or quality control for cGMP manufacturing.
• 1-3 years’ experience designing or implementing business processes or SAP systems.
• Experience implementing changes under cGMP change control.
• Expert knowledge of cGMP quality systems and intermediate knowledge of SAP.
• Experience writing or maintaining procedures and process documentation.
• Experience with Good Manufacturing Practices and Good Documentation Practices.
• Experience in change control, CAPA, or deviation investigations.
• Strong communication and on-site collaboration.

Responsibilities

• Act as the Quality Assurance oversight to Production SAP use, business rules, outcomes and compliance including creation of new material master data.
• QA Oversight for Serialization Line client recipe creation and modification.
• Key contact for internal departments and other sites for information and assessment and distribution regarding master data.
• Act as site Quality Consultant for SAP when issues arise.
• Provide input to global procedural revisions in order to ensure site Master Data needs are being addressed to improve standing with GQA.
• Act as Quality Assurance oversight of QC Master Data, ensuring adherence to procedures, policies, standards and FDA regulations.
• Be SME for local SOPs where SAP is utilized as well as QA approver / compliance authority for QC SOPs relating to QC master data, ensuring.
• No conflict between site processes, compliance with CFR requirements and GSK higher level documents, consistent use of SAP across departments, consistency/ clarity between all relevant processes, ease of use for local departments, opportunities for improvement are identified and implemented and clear traceability, visibility and accuracy of decision-making processes.
• Train users related to SAP business processes.
• Assist with QA Systems objects (including deviations, change controls and CAPA involving SAP use.
• Lead the design, documentation and maintenance of quality unit business processes and standard operating procedures.
• Work with cross-functional teams to translate operational and technical requirements into practical process controls.
• Support change control, risk assessments and quality impact evaluations for process and system changes.
• Contribute to investigations, root cause analysis and corrective and preventive actions to prevent recurrence.
• Monitor quality metrics and trends and recommend process improvements to reduce risk and improve performance.

Skills

QA

GxP Regulations

Data Integrity

Risk Awareness

Problem Solving

Technical Writing

Lean Management

Digital Fluency

Influencing

Regulatory Compliance

CFR Knowledge

Education

Bachelor's in Life Sciences/Engineering

Tools

SAP

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 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: The Quality Unit Business Process Specialist is responsible for quality oversight of SAP processes, business rules, and systems used and the inter-relatedness between each process, rule, or system in order to identify opportunities for improvement and to avoid conflict between processes and systems. As a member of the Quality Assurance Operations, this position is co -responsible for the site and the department results. You will act as a Quality Unit Business Process Specialist supporting a United States manufacturing site. You will partner day-to-day with operations, engineering, IT and quality teams to design, implement and sustain quality processes that keep production compliant and reliable. You will help translate business needs into clear, documented processes and support continuous improvement. We value people who are practical, curious, and ready to coach others. This role offers visible impact, learning and growth aligned with our mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities

• Act as the Quality Assurance oversight to Production SAP use, business rules, outcomes and compliance including creation of new material master data.
• QA Oversight for Serialization Line client recipe creation and modification.
• Key contact for internal departments and other sites for information and assessment and distribution regarding master data.
• Act as site Quality Consultant for SAP when issues arise.
• Provide input to global procedural revisions in order to ensure site Master Data needs are being addressed to improve standing with GQA.
• Act as Quality Assurance oversight of QC Master Data, ensuring adherence to procedures, policies, standards and FDA regulations.
• Demonstrated familiarity and compliance with cGMPs, EHS procedures and regulations, facility regulatory guidelines and standard operating procedures.
• Be SME for local SOPs where SAP is utilized as well as QA approver / compliance authority for QC SOPs relating to QC master data, ensuring.
• No conflict between site processes, compliance with CFR requirements and GSK higher level documents, consistent use of SAP across departments, consistency/ clarity between all relevant processes, ease of use for local departments, opportunities for improvement are identified and implemented and clear traceability, visibility and accuracy of decision-making processes.
• Train users related to SAP business processes.
• Assist with QA Systems objects (including deviations, change controls and CAPA involving SAP use.
• Lead the design, documentation and maintenance of quality unit business processes and standard operating procedures.
• Work with cross-functional teams to translate operational and technical requirements into practical process controls.
• Support change control, risk assessments and quality impact evaluations for process and system changes.
• Contribute to investigations, root cause analysis and corrective and preventive actions to prevent recurrence.
• Monitor quality metrics and trends and recommend process improvements to reduce risk and improve performance.

Basic Qualifications

• Bachelor’s degree in life sciences, engineering, quality, or a related technical field.
• 3-5 years’ experience in cGMP production or quality control for cGMP manufacturing.
• 1-3 years’ experience designing or implementing business processes or SAP systems.
• Experience the implementation and changes must be performed under cGMP change control.
• Expert knowledge cGMP quality systems and at intermediate knowledge of SAP or business processes ensures that candidates possess the skills to perform quickly in this position.
• Practical experience writing or maintaining procedures, work instructions, or process documentation.
• Experience with Good Manufacturing Practices and Good Documentation Practices.
• Experience participating in change control, CAPA, or deviation investigations.
• Strong verbal and written communication skills and ability to work on-site with cross-functional teams.

Preferred Qualifications

• Experience in biologics or pharmaceutical manufacturing environments with computerized systems or digital manufacturing tools such as MES, LIMS or Green belt certification.
• Experience with risk assessment tools and verification of mitigation actions.
• Training or experience in structured root cause analysis methods such as DMAIC or similar.
• Proven ability to influence and coach colleagues across functions and levels.
• Experience monitoring and reporting quality KPIs and using data to drive improvements.

Work Arrangements

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

Benefits

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

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. 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.

Equal Opportunity & 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.

Employment Agency Notice

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Transparency and CMS Information

For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Final note

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.