Senior Manager, Quality Assurance
Company: Just - Evotec Biologics
Location: Seattle
Posted on: May 16, 2022
Job Description:
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.Responsibilities:
- 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 risksEducational Requirements:
- Bachelors degree in biological or engineering science with 8+
years relevant experiencePreferred Qualifications:
- 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 teamsMiddle Management
Keywords: Just - Evotec Biologics, Seattle , Senior Manager, Quality Assurance, Executive , Seattle, Washington
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