Quality Unit Business Process Specialist

GSK; United States; On-site; USD 85,000 - 115,000; Full time

Job summary

GSK is seeking a Quality Unit Business Process Specialist for a United States manufacturing site. You will partner with operations, engineering, IT and quality to design, implement and sustain quality processes that keep production compliant and reliable.

You will translate business needs into documented processes, provide SAP QA oversight, train users, and support change control and CAPA while driving continuous improvement across the site.

Qualifications

• 3–5 years in cGMP production or quality control for cGMP manufacturing.
• 1–3 years designing or implementing business processes or SAP systems.
• Experience with cGMP change control; proficient in quality systems and SAP/business processes.
• Experience writing procedures, work instructions, or process documentation; familiarity with GMP and GDP.
• Strong verbal and written communication; ability to work on-site with cross-functional teams.

Responsibilities

• Provide QA oversight of SAP use, data, and master data creation.
• Serve as site Quality Consultant for SAP; contribute to procedural revisions.
• Oversee QC Master Data per procedures and CFR alignment.
• Train users on SAP business processes.
• Lead design, documentation, and maintenance of quality unit processes and SOPs.
• Support change control, risk assessments, and CAPA related to SAP.
• Monitor quality metrics and drive process improvements.
• Collaborate with operations, engineering, IT and quality teams.

Skills

cGMP knowledge

Quality systems

SAP familiarity

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in life sciences, engineering, quality, or related technical field

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 t he 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 phar