Senior Manager/Director, Quality Assurance

Location
Seattle, WA
Posted
Jul 19, 2019
Ref
1514846040
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
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 but 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 through Commercial stages. 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
  • Direct and manage the QA review and approval of Master Batch Records, Executed Batch Records, and analytical testing.
  • Direct and manage the QA assessment and review, including investigations and approval of NC/CAPA documentation.
  • Execute product disposition and release
  • Manage the QA communication and lot disposition process with CDMO client base.
  • Organize and conduct internal and external audits of the quality assurance management system
  • Assist in and monitor Change Control, Validation, and Risk Management activities
  • Implement process performance and product quality monitoring programs
  • Assist in IND and BLA regulatory submissions
  • Host and interact with regulatory agency representatives
  • Investigate complaints and adverse events
  • Collect and compile statistical quality data
  • Alert senior management of significant quality, compliance, supply and safety risks

Educational Requirements:
  • Bachelors degree in biological or engineering science with 10+ years relevant experience

Preferred Qualifications:
  • Certifications, including Quality Auditor, Quality Engineer, Six Sigma
  • Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company
  • Comprehensive understanding of relevant regulatory requirements
  • Expertise in tools, concepts, and methodologies of QA
  • Strong computer skills including Microsoft Office and databases
  • Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and teamwork

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.