Senior Manager/Director, Quality Assurance

Location
Seattle, WA, United States
Posted
Apr 23, 2021
Ref
271838081
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 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 for Phase 1/2. 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, 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
  • Organize and conduct internal and client 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 regulatory submissions
  • Host and interact with regulatory agency representatives
  • Investigate complaints and adverse events
  • 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 Phase 1/2 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

About Just - Evotec Biologics

Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 200 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers