Quality Unit Business Process Specialist - Drug Substance

What you'll do

• Provide quality oversight, maintain process documentation and SOPs, and advise cross-functional teams on quality processes and changes.
• Support quality investigations, root cause analysis, CAPA, impact assessments, and risk reviews.
• Train and coach colleagues on quality processes, documentation, and compliance.

What they ask for

• Bachelor’s degree in life sciences, engineering, quality, or a related technical field.
• At least 3 years’ experience in cGMP production, quality control, or quality assurance in a regulated life sciences environment.
• Experience designing, implementing, or supporting quality business processes; preferably involving SAP or similar ERP.
• Practical knowledge of GMP, GDP, and regulatory compliance; experience with change control, CAPA, deviations, or quality investigations.

Nice to have

• Pharmaceutical or biologics manufacturing experience, especially with computerized manufacturing systems; familiarity with LIMS, MES, or electronic batch records.
• Training or experience in structured root cause analysis and risk assessment; audit readiness, coaching, or continuous improvement experience.

Tools

SAP, ERP, LIMS, MES, electronic batch records