Quality Unit Business Process Specialist - Drug Substance

Position Summary

Join us as a Quality Unit Business Process Specialist supporting drug substance operations at a United States site. You will collaborate daily with manufacturing, quality, IT, and engineering teams to ensure quality processes run smoothly and compliantly. Your role will focus on overseeing quality systems, identifying improvement opportunities, and coaching colleagues to maintain high standards.

Responsibilities

• Provide quality oversight for drug substance-related business processes and systems, ensuring compliance with regulations and internal standards.
• Act as a key quality contact for cross-functional teams and sites on master data, process changes, and procedural questions.
• Develop, review, and maintain quality unit business process documentation and standard operating procedures (SOPs).
• Support investigations, root cause analysis, and corrective and preventive actions related to quality deviations and process issues.
• Facilitate quality impact assessments and risk reviews for process and system changes.
• Train and coach site colleagues on quality processes, documentation practices, and compliance requirements.

Basic Qualifications

• Bachelor's degree in life sciences, engineering, quality, or a related technical field.
• Minimum 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 Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory compliance.
• Experience participating in change control, CAPA, deviations, or quality investigations.
• Strong verbal and written communication skills and ability to work collaboratively on-site with cross-functional teams.

Preferred Qualifications

• Experience in pharmaceutical or biologics manufacturing environments, particularly with computerized manufacturing systems.
• Familiarity with laboratory information management systems (LIMS), Manufacturing Execution Systems (MES), or electronic batch records.
• Formal training or experience in structured root cause analysis and risk assessment techniques.
• Proven ability to influence and coach colleagues at different levels and from multiple disciplines.
• Experience maintaining inspection readiness and supporting regulatory audits.
• Demonstrated focus on continuous improvement through monitoring of quality metrics and KPIs.

Work Arrangement

This role is on-site at a United States manufacturing location with regular presence required in production and laboratory areas. Hybrid or remote work is not available.