# Quality Unit Business Process Specialist

**Company**: GSK
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Marietta/Quality-Unit-Business-Process-Specialist_446953?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_da04f7b0-c1c

## Description

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.

Responsibilities:

- Act as the Quality Assurance oversight to Production SAP use, business rules, outcomes and compliance including creation of new material master data.

- 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.

- 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.

- 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.

- Practical experience writing or maintaining procedures, work instructions, or process documentation.

- 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.

- Experience with risk assessment tools and verification of mitigation actions.

- Training or experience in structured root cause analysis methods.

- Proven ability to influence and coach colleagues across functions and levels.

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.

## Skills

### Required
- 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

### Nice to have
- Experience in biologics or pharmaceutical manufacturing environments
- Risk assessment tools
- Structured root cause analysis methods

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