Startup Careers

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Director of Quality at Synthego
Redwood City, CA, US
We are seeking a qualified individual to join us as the Director of Quality. This position reports to the Chief Operating Officer and has direct responsibility for the Quality Assurance and Regulatory Affairs functions of the organization.

What You'll Do

    • Develop cGMP Quality Systems from the ground up to ensure that Synthego is compliant with relevant regulations
    • Maintain up-to-date knowledge of the GMP landscape, regulations, and guidelines
    • Responsible for developing and submitting Drug Master File
    • Oversee Quality Management Systems including Deviations, CAPAs,  Document Control, Training and Customer Complaints
    • Review and approve Risk Assessments, Process Development Reports, and Protocols
    • Quality oversight of the validation system to ensure quality and compliance requirements are met in an efficient and effective manner
    • Responsible for the development of GMP-compliant validation activities for manufacturing processes, facilities, equipment, environmental controls, and software.
    • Review/approve deviations, CAPAs, SOPs, and operational documents in a timely manner
    • Responsible for vendor qualification, auditing, and quality agreements
    • Manage investigations, due diligence assessments, regulatory agency inspection activities
    • Ownership of incoming inspection, non-conforming material, and supplier corrective actions
    • Manage contract testing lab(s)
    • Responsible for batch record review and lot release activities
    • Partner with product development to design product release tests and specifications 
    • Manage, develop and mentor quality team

About You

    • Bachelor's degree required. Advanced scientific degree strongly preferred
    • Minimum of 10 years of relevant experience in Life Sciences; GMP experience required
    • Broad understanding of FDA regulations and guidance documents
    • Experienced manager of other full-time employees as well as contractors
    • Demonstrated experience as a player/coach 
    • Well-prepared, competent, and confident when interacting with senior management, regulatory authorities, and internal and external partners
    • Demonstrated ability to move at a rapid pace
    • Ability to remain objective/autonomous in overseeing the Quality Program, while at the same time taking ownership and proactively working with the rest of the team to achieve the desired quality objectives
    • Track record of successful leadership of cross-functional projects
    • Excellent interpersonal, verbal, and written communication skills

Company Benefits & Perks

    • Competitive salary
    • Generous equity at an early stage company
    • Robust medical, dental and vision benefits
    • 401k Plan
    • Fully stocked kitchen and snacks
    • Free catered lunches and dinners 
    • 4x daily Shuttle bus to & from San Francisco
ABOUT SYNTHEGO
 
Synthego’s vision is to turn biology into an information science, with the ultimate goal of dramatically extending the healthy human lifespan.
 
Synthego builds advanced bioinformatics and automated hardware platforms to create next-generation molecular biology tools, starting with full-stack genome engineering.
 
These world-class tools accelerate basic scientific discovery, critical disease cures and novel synthetic biology applications to improve and prolong life.