Supplier Quality Manager, Quality Assurance

Location
Redmond, WA, United States
Posted
Oct 11, 2020
Ref
977263510
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Just is seeking a highly motivated Quality Manager that desires a significant opportunity to be part of a team focused on improving worldwide access to Biotherapeutics. This individual will join the Quality team at Just with their primary responsibility to build and enhance the quality assurance systems supporting the Supplier Quality management and raw materials programs. The ability to work both independently and collaboratively with operations staff across multiple disciplines in a fast-paced and dynamic environment are essential to be successful in this position.

Responsibilities
  • Oversee and develop the Supplier Quality program, including supplier selection (working with Procurement), qualification, audit, and performance metrics monitoring, using Quality Risk management tools
  • Enhance current raw material Quality management programs, including incoming testing and release, to meet phase-appropriate compliance requirements
  • Support the Supplier Complaint/NC/CAPA and change control programs, and collaborate with manufacturing, warehouse, QC, and suppliers to determine cause, corrective action, and impact for deviations and complaints.
  • Provide quality/compliance subject matter expertise to the Procurement, Supply Chain and project teams in support of new projects, technical transfer, supplier selection programs
  • Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures , and instructions for all activities in which the team participates.
  • Works collaboratively with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality issues as well as maintain GMP compliance.

Requirements
  • Bachelor's degree in biological sciences, chemistry, biochemistry, engineering, or related life science field.
  • 6 - 10+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.

Preferred Qualifications
  • Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies to ensure compliance.
  • Experience in Quality Control/Assurance/Operations for late state clinical manufacturing or commercial qualification drug substance campaigns; commercial campaign support is a plus.
  • Familiarity with Quality Agreement negotiations
  • Supplier (chemical, disposable, DS/DP manufacturers, etc.) audit and Regulatory Inspection experience
  • Excellent verbal and written communication skills.
  • Strong focus on quality and attention to detail.
  • Possess effective task/time management organization skills
  • Leadership and staff mentoring

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 100 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