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Associate Director/ Director of Quality Assurance

Synthego

Synthego

Quality Assurance
Redwood City, CA, USA
Posted on Tuesday, June 4, 2024
The Associate Director/Director of Quality Assurance, reporting to VP of Quality & Regulatory, will be responsible for Quality Assurance and Validation team to ensure that the Quality management system and all aspects of cGMP are effectively established, implemented, and maintained in accordance with the regulations for manufacturing of guide RNAs for gene therapy applications. This individual, as the head of QA Department, will be responsible for leading and managing QA operations, Quality events, product disposition, and validation activities.

What You'll Do:

  • Provide QA oversight for facility, equipment, manufacturing, testing and release of preclinical and clinical guide RNAs
  • Manage incoming raw materials and product disposition activities
  • Provide direct oversight for major investigations/non-conformance events including out of specification events
  • Provide oversight for commissioning, qualification and validation activities for the facilities, utilities equipment and computerized systems
  • Support audit programs and host customer audits and regulatory inspections
  • Manage all QA-related interactions with customers including timely client notification and compliance to quality agreement terms
  • Work closely with cross-functional teams including Regulatory and Compliance, QC, Manufacturing, Facility, Engineering, and Supply Chain to enforce quality and compliance requirements
  • Lead Quality Management Review and ensure the effectiveness of the Quality Management System by proactive gap assessment and remediation
  • Responsible for trending, reporting, and improving KPI metrics for QA and Validation, including timely closure of quality events and adherence to schedule for product disposition
  • Manage and mentor QA and Validation personnel and oversee their performance management and career development

About You:

  • Minimum Bachelor’s degree with 10 years experience in GMP environment in Life Sciences (advanced degree is preferred and counts as years of experience)
  • Minimum 6 years job experience in Quality, with at least 3 years management experience in Quality Assurance and Validation
  • 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:

  • Equity options
  • Medical, dental, and vision benefits
  • 401k Program
  • Fully stocked kitchen with beverages & snacks
  • Paid parental leave
  • Flexible paid time off
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.