The Director of Quality Assurance will report directly to the COO and will be responsible for assuring consistent quality of production by developing and enforcing ISO13485 and Current Good Manufacturing Practice (cGMP) systems meeting the requirements of US and EU regulations and guidelines; establishing and maintaining robust Quality Systems, establishing, implementing and assuring compliance with QA Policies and Procedures, management of documentation control and managing the non-conformance and batch record/lot release systems.
- Formulate, establish and maintain policies and procedures and accompanying Quality Systems related to cGMP manufacturing while that ensuring these systems are in compliance with US FDA and global regulatory requirements
- Establish and maintain an overall Quality System to support clinical and commercial cGMP activities. Manage cGMP document control system
- Provide subject matter assistance for the development of Quality Documents
- Assist in the development, codification and implementation of Quality Control Systems
- Coordinate and provide oversight of lot release for bulk reagents, RNA/DNA product and packaged product for clinical and commercial use
- Include timely management of batch record review, resolution of deviations/con-conformances, review and approval of in-process and lot release testing records, issuance of Certificates of Conformance and Certificates of Analysis
- Establish and maintain a robust and compliant non-conformance management system / processes and CAPA system / processes. Establish/maintain corporate Change Control processes
- Apprise senior management of critical issues
- Manage cGMP QA/QC team members to ensure efficient and effective QA operations and to ensure that QA initiatives are consistent with and advance company objectives and within approved budgets
- Maintain an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Quality System activities
- Broad knowledge of Quality System implementation and maintenance including, but not limited to, batch records review and lot release, non-conformance management, effective CAPA programs, and Change Control programs
- Knowledge and experience with Risk-based approach to Quality System implementation
- Strong analysis and problem solving skills
- Ability to lead in cross functional teams in problem resolution
- Ability to work in a dynamic, fast paced environment with shifting priorities
- Bachelor's Degree in Chemistry, Biology or a related scientific discipline, or equivalent work experience
- 10+ years experience in the biotech/biopharma/pharma industry required
- 5+ years working in progressively responsible positions in Quality
- 3+ years of Management/Supervisory experience is required
- Previous experience working with products registered globally
- Knowledge with cGMP and FDA/EMA biologics, cellular and human gene therapy regulations preferred but not required
- Knowledge with Aseptic Processing regulations and guidelines
- Experience with process and analytical validation
- Demonstrated ability to evaluate manufacturing conditions and lot-specific data in order to disposition products
- Proven ability to develop effective corrective and preventive actions
- Graduate degree in Chemistry, Biology or a related scientific discipline
- Knowledge in production of human gene therapy products preferred
- Experience with pharmaceutical products intended for human use
Company Perks & Benefits
- 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
Synthego is turning molecular biology into an information science. We're building hardware facilities that abstract biological syntheses and research into software.
Our vision is to bring automation to genome engineering, enabling scientists to run their own fully-automated laboratory at low cost, performing millions of controlled, repeatable experiments per day without human error.
Founded by former SpaceX engineers, Synthego is a leading provider of genome engineering solutions. The company’s flagship product, CRISPRevolution, is a portfolio of synthetic RNA designed for CRISPR genome editing and research.
We are venture backed by Founders Fund, Menlo Ventures, 8VC, and WI Harper.