Just Evotec Biologics is looking for a Senior Manager, QA Quality Management Systems to manage and improve their Quality Management System operations, specifically focusing on deviation, CAPA, and change control processes, to ensure quality, compliance, and drive innovation.
Requirements
- Expertise in tools, concepts, and methodologies of QA.
- Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES.
- Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making.
- Experience in helping to build and maintain a Quality infrastructure.
- Root cause analysis and classification, development of effective CAPA to address root and contributing causes.
- Monitoring and tracking performance metrics related to QMS records.
- Participate in strategic development of Quality Systems
Responsibilities
- Overall responsibility for operations of the deviation, CAPA, and change control processes.
- Lead group of QA Specialists and Sr. Specialists (5-7 people) that review and approve QMS records.
- Root cause analysis and classification, development of effective CAPA to address root and contributing causes.
- Approve major and critical deviations.
- Monitoring and tracking performance metrics related to QMS records.
- Participate in and help implement process improvements.
- Compile and analyze group KPIs. Lead process improvement activities specific to their area of responsibility
Other
- Bachelor’s degree in biological or engineering science with 8+ years relevant experience
- Minimum 3 + years of management experience
- Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams.
- traveling to Seattle site once a week or as required
- A curious problem-solver with a passion for learning and growing in a dynamic environment.
