The Sr. Director of Quality Assurance at Twist is responsible for building and maintaining the Twist Quality Management System (QMS). This individual designs quality programs that will satisfy customer requirements for each individual product line. The QA Sr Director is responsible for achieving and maintaining the appropriate ISO and/or regulatory certifications for each business unit. He/she will manage an international QA team that will ensure appropriate quality objectives are met.
- Manage local and global QA teams
- Select, build, and maintain an EDMS for QMS
- Ensure maintenance of job descriptions
- Establish and maintain training records
- Build and maintain a CAPA system
- Achieve and maintain 13485:2016 certification as appropriate per product line
- Achieve and maintain 9001:2015 certification as appropriate per product line
- Achieve and maintain 27001:2013 and 27002:2013 certification
- Conduct QA management reviews
- Oversee QMS compliance for all personnel and disciplines
- Ensure supplier quality objectives are met
- Establish and maintain an internal audit schedule
- Conduct internal audits
- Establish product development lifecycle with appropriate design controls
- Establish SW development lifecycle with appropriate design controls
- Build and maintain a change control system
- Establish monitoring and measuring systems
- Create customer complaint and feedback tracking
- Implement continuous improvement
- Ph.D. in Biochemistry, Molecular Biology, Microbiology, Bioengineering, or related field and fifteen years of experience in the area of technology transfer
- At least 10 years GxP experience
- In-depth knowledge of ISO 9001:2015 and 13485:2016
- Ability to communicate effectively both verbally and in writing
- Demonstrated knowledge of product development lifecycle, including the ability to guide large-scale programs toward commercialization goals
- Strong supervisory and organizational abilities
- Demonstrated experience in product commercializing
About Twist Bioscience
Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.
San Francisco applicants: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.