Quality Assurance - Associate Director, Quality Systems & Compliance (QSC)

The Associate Director of Quality Systems and Compliance (QSC), reporting to VP of Quality & Regulatory, will be responsible for the GxP Quality Systems, ensuring continuous process improvement and compliance to applicable standards and regulations (e.g. ISO 9001, 21 CFR Parts 11, 210, and 211). This role will be responsible for Change Management, Training Program, Documentation Management, Date Integrity, Risk Assessment, Supplier Management, and Audit Program.

What You'll Do

• Responsible for electronic Quality Management System (eQMS) used for Documentation, Training, and Quality Records including Change Management and CAPAs
• Manage and Improve Internal, External, and customer Audits and associated CAPAs
• Manage and Improve Supplier Qualification Program
• Manage and Improve Training Program
• Manage and Improve Documentation Control Program
• Improve Risk Management and Data Integrity Programs
• Proactively monitor the various elements of the quality system to ensure phase-appropriate compliance with applicable regulations and standards
• Responsible for the timely issuance of quality related documentation (Change controls, CAPAs, Deviations, etc.) and the generation of KPI reports as well as the tracking of actions and follow ups for completion
• Responsible for mentoring, and developing the Quality Systems team to support business operations and employee career development

About You

• Minimum Bachelor’s degree with 12 years experience in GMP environment in Life Sciences  (advanced degree is preferred and counts as years of experience)
• Minimum 5 years job experience in Quality Assurance, with at least 2 years direct working experience in Quality Systems and Compliance, especially Training, Document Control, Audit, and Supplier Management 
• Working knowledge of ISO 9001, 21 CFR Part 210 and 211, 21 CFR Part 11
• Excellent planning, prioritizing and project management skills and the ability to apply these skills effectively to ensure timely delivery in a fast pace environment. 
• Excellent oral/written communication skills, including facilitation and presentation skills. 
• Excellent interpersonal skills, including leadership, influencing, and relationship-building across functions.

Company Perks & Benefits

• Generous equity
• Medical, dental, and vision benefits
• 401k Program
• Subsidized catered lunches and dinners with stocked kitchens & snacks
• Onsite Gym
• Paid parental leave
• Flexible paid time off
• Learning and Development resources 

About Us Synthego is a genome engineering company that enables the acceleration of life science research and development in the pursuit of improved human health.
The company leverages machine learning, automation, and gene editing to build platforms for science at scale. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.
By providing both commercial and academic researchers and therapeutic developers with unprecedented access to cutting-edge genome engineering, Synthego is at the forefront of innovation, accelerating the development of truly engineered biology.