Manager, Quality Assurance

Manager, Quality Assurance | Just. – Redmond, WA |

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
• Lead the Quality Assurance team responsible for the quality batch record review on the Manufacturing floor
• Manage the QA communication and lot review process with CDMO client base
• Responsible for the Compliance walkthrough across the Redmond site -including but not limited to Manufacturing floor.
• Partner with Manufacturing to ensure compliance on the Manufacturing floor.
• Responsible for triage events and support investigations for NC and CAPA
• Responsible for QA assessment, review and approval of Change Control and Documents.
• Support QA review and approval of Master Batch Records, Executed Batch Records, EBRs, Product Specifications and Quality Control Analytical data.
• Support product disposition and release of Drug Substance and intermediates
• 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

Educational Requirements:

• Bachelors degree in biological or engineering science with 8+ years relevant experience

Preferred 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 teams

About Just

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 and first North American J.POD® commercial manufacturing facility in the Seattle area.

The base pay range for this position at commencement of employment is expected to be $125,000 to $155,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision and 401k company match, flexible paid time off and paid holiday, wellness and transportation benefits.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.