Senior Manager, Quality Assurance
Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products. The ideal candidate will have significant experience in leading all Quality Assurance and batch disposition activities related to the manufacturing of biological products from Phase 1 to PPQ to commercial. Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.
- Lead and direct all aspects of the Quality Assurance function to assure compliance with quality and industry regulatory requirements
- Support QA review and approval of Master Batch Records, Executed Batch Records, EBRs, Product Specifications and Quality Control Analytical data.
- Direct and manage the QA assessment and review of investigations and approval of NC/CAPA/Change control documentation.
- Execute product disposition and release of Drug Substance and intermediates
- Manage the QA communication and lot disposition process with CDMO client base
- Support internal and client audits of the quality management systems
- Implement process performance and product quality monitoring programs
- Continue to build and enhance various Quality Assurance programs by guiding individuals through the maturation process.
- Implement phase appropriate programs that allow technical and scientific flexibility depending on the stage of the clinical program.
- Alert senior management of significant quality, compliance, supply and safety risks
- Bachelors degree in biological or engineering science with 8+ years relevant experience
- Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company
- Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making
- Expertise in tools, concepts, and methodologies of QA
- Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES
- Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams