Quality Unit SAP & Process Specialist - GMP Compliance

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

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.