Key skills
SAPLeadershipRisk ManagementTeam LeadershipCommunicationDecision MakingCritical Thinking
About this role
Role Overview
- Lead the QA Disposition group to ensure compliant and efficient disposition of materials and products
- Perform QA disposition of Cell Banks and DS batches manufactured at Just Evotec Biologics
- Perform QA disposition of Cell Banks and DP batches manufactured at contracted CMOs
- Execute raw material disposition to support manufacturing schedules and supply continuity
- Manage QA communication and disposition workflows with CDMO client partners
- Oversee DS/DP shipments to CMOs for fill/finish operations
- Support shipment of DS/DP vials for labeling, stability studies, or other testing needs
- Support internal and client audits of the Quality Management System
- Implement and maintain process performance and product quality monitoring programs
- Guide team members and cross-functional partners through the development and maturation of Quality Assurance programs
- Implement phase-appropriate quality programs that balance scientific flexibility with compliance expectations
- Identify, escalate, and communicate significant quality, compliance, supply, or safety risks to senior leadership
- Identify and escalate compliance risks within the disposition function
- Participate in the strategic development and continuous improvement of Quality Systems
- Compile, analyze, and report team KPIs; lead process improvement initiatives within the disposition area
Requirements
- Bachelor’s degree in a biological or engineering discipline
- 8+ years of relevant industry experience
- Minimum of 3 years of people management experience
- Demonstrated experience building and sustaining Quality infrastructure in a growing organization
- Strong critical thinking skills with understanding of biologics regulatory requirements, risk management principles, and science-based decision making
- Expertise in Quality Assurance tools, concepts, and methodologies
- Proficiency with Microsoft Office and electronic quality systems (eQMS), including CMMS and SAP
- Strong competencies in communication (written and verbal), attention to detail, data management and analysis, sound judgment, decision-making, and team leadership.
Benefits
- discretionary annual bonus
- comprehensive benefits to include Medical, Dental and Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- generous paid time off
- paid holiday
- wellness and transportation benefits