Quality Unit Business Process Specialist
GSK
August 31, 2026
On-site
Marietta, PA
Operations
Position Summary:
The Quality Unit Business Process Specialist provides quality oversight of SAP processes, business rules, and systems, ensuring inter-relatedness between processes and systems to identify improvement opportunities and avoid conflicts. Partners with operations, engineering, IT, and quality teams to design, implement, and sustain compliant, reliable quality processes.
Responsibilities:
- Provide QA oversight for Production SAP use, business rules, outcomes, and compliance, including creation of new material master data and serialization line client recipe creation/modification.
- Serve as key contact for internal departments and other sites regarding master data information, assessment, and distribution.
- Act as site Quality Consultant for SAP issues; contribute input to global procedural revisions.
- Provide QA oversight for QC master data, ensuring adherence to procedures, policies, standards, and FDA regulations.
- Demonstrate familiarity/compliance with cGMPs, EHS procedures and regulations, facility regulatory guidelines, and SOPs.
- Be SME for local SOPs where SAP is utilized; QA approver/compliance authority for QC SOPs relating to QC master data; ensure CFR compliance and clarity/traceability across processes.
- Train users on SAP business processes.
- Assist with QA systems objects (deviations, change controls, CAPA involving SAP use).
- Lead design, documentation, and maintenance of quality unit business processes and SOPs.
- Support change control, risk assessments, quality impact evaluations, investigations, root cause analysis, and corrective/preventive actions.
- Monitor quality metrics/trends and recommend improvements.
Basic Qualifications:
- Bachelor’s degree in life sciences, engineering, quality, or related technical field.
- 3–5 years’ experience in cGMP production or cGMP quality control; 1–3 years designing/implementing business processes or SAP systems.
- Experience implementing changes under cGMP change control; strong cGMP quality systems knowledge; intermediate SAP/business process knowledge.
- Experience writing/maintaining procedures, work instructions, or process documentation; GMP and GDP practices; experience with change control, CAPA, or deviation investigations.
- Strong verbal/written communication; ability to work on-site with cross-functional teams.
Preferred Qualifications:
- Biologics/pharmaceutical manufacturing experience with computerized systems/digital tools (MES, LIMS) or Green Belt certification.
- Risk assessment and verification of mitigations; structured root cause analysis (e.g., DMAIC); ability to influence/coach.
- Experience monitoring/reporting quality KPIs and using data for improvements.
Work Arrangements:
- On-site at a US manufacturing location; regular presence in production and laboratory areas required; hybrid/remote not available.
How to Apply:
- Apply and describe how experience fits responsibilities/qualifications; include examples of process improvements led and how you supported teammates through change.
The Quality Unit Business Process Specialist provides quality oversight of SAP processes, business rules, and systems, ensuring inter-relatedness between processes and systems to identify improvement opportunities and avoid conflicts. Partners with operations, engineering, IT, and quality teams to design, implement, and sustain compliant, reliable quality processes.
Responsibilities:
- Provide QA oversight for Production SAP use, business rules, outcomes, and compliance, including creation of new material master data and serialization line client recipe creation/modification.
- Serve as key contact for internal departments and other sites regarding master data information, assessment, and distribution.
- Act as site Quality Consultant for SAP issues; contribute input to global procedural revisions.
- Provide QA oversight for QC master data, ensuring adherence to procedures, policies, standards, and FDA regulations.
- Demonstrate familiarity/compliance with cGMPs, EHS procedures and regulations, facility regulatory guidelines, and SOPs.
- Be SME for local SOPs where SAP is utilized; QA approver/compliance authority for QC SOPs relating to QC master data; ensure CFR compliance and clarity/traceability across processes.
- Train users on SAP business processes.
- Assist with QA systems objects (deviations, change controls, CAPA involving SAP use).
- Lead design, documentation, and maintenance of quality unit business processes and SOPs.
- Support change control, risk assessments, quality impact evaluations, investigations, root cause analysis, and corrective/preventive actions.
- Monitor quality metrics/trends and recommend improvements.
Basic Qualifications:
- Bachelor’s degree in life sciences, engineering, quality, or related technical field.
- 3–5 years’ experience in cGMP production or cGMP quality control; 1–3 years designing/implementing business processes or SAP systems.
- Experience implementing changes under cGMP change control; strong cGMP quality systems knowledge; intermediate SAP/business process knowledge.
- Experience writing/maintaining procedures, work instructions, or process documentation; GMP and GDP practices; experience with change control, CAPA, or deviation investigations.
- Strong verbal/written communication; ability to work on-site with cross-functional teams.
Preferred Qualifications:
- Biologics/pharmaceutical manufacturing experience with computerized systems/digital tools (MES, LIMS) or Green Belt certification.
- Risk assessment and verification of mitigations; structured root cause analysis (e.g., DMAIC); ability to influence/coach.
- Experience monitoring/reporting quality KPIs and using data for improvements.
Work Arrangements:
- On-site at a US manufacturing location; regular presence in production and laboratory areas required; hybrid/remote not available.
How to Apply:
- Apply and describe how experience fits responsibilities/qualifications; include examples of process improvements led and how you supported teammates through change.