Programmable DNA, the software of Life, is finally here! Twist Bioscience is developing a disruptive Synthetic DNA technology that will change the world, enabling widespread health and sustainability. Synthetic biologists will use our products to engineer how organisms produce cures to diseases, make everyday chemicals by using the atmosphere as the carbon source, enable plants to make their own fertilizers, and to create in-vivo diagnostics that alert us when we are sick, and many more applications.
Manager, Quality Systems
The Quality Systems Manager is responsible for leadership of various quality functions that support the design and transfer of compliant in vitro diagnostics (medical devices) including product transfer, supplier quality, internal auditing, CAPA, document control, and training. This position provides leadership regarding the release, structure and change of all controlled documentation in addition to having a charter to make the Quality Management System as lean and compliant as possible. The Quality Systems Manager oversees the training responsibilities for the site as well as providing guidance for the supplier quality function. The Quality Systems Manager will interact with individuals at multiple levels within all functional departments, including Quality Assurance Engineering, Software Quality Assurance, R&D, and Marketing in addition to building relationships with partners that manufacture products for the South San Francisco site.
- Drive changes to the Quality System as needed to maintain compliance and improve effectiveness and efficiency
- Ensure meaningful quality metrics are created, implemented, trended, and analyzed for the organization
- Supervise the Documentation and Training functions
- Review Production Issues (PI), nonconformance’s, and deviations according to established procedures to ensure compliance.
- Manage CAPA program, which includes the management of robust CAPA Training program.
- Create and report on key metrics regarding Supplier Issue Ticket closure, CAPA ticket closure, and Production Issue Ticket closure and customer complaints.
- Responsible for problem solving and escalated Production Issue management.
- Support site implementation and on-going maintenance of the electronic document and learning management systems
- Ensure the timely and accurate retrieval of documentation records and personnel training and qualifications to support internal and external audits and regulatory inspections
- Assist with the generation and/or revision of GMP documentation
- Assist in scheduling Internal Audits and managing the Internal Audit Schedule.
- Coordinates and participates in Internal Audits in addition to Supplier Audits.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
- Ensure training compliance is tracked, trended, and monitored
- Ensure document control change request process is tracked for efficiency
- Ensure document approval matrices and delegation authorities are updated
- Ensure annual reviews of controlled documents are performed as required
- Ensure historical files for Device Master Records (DMR), Device History Records (DHR), SOP’s, training records, and other quality system documents are maintained.
- Ensure archival activities are completed for obsoleted controlled documents
- Support regulatory (FDA, Certification Body, Notified Body) audits/inspections
- Support Customer audits/visits
- Collaborate with manufacturing partner(s) related to the product transfer process
- Maintains strong communication network with peers.
- Demonstrated leadership, motivational and organizational skills with a proven track record of accomplishments in cross-functional projects/teams/programs
- Ensure the Quality Systems group is appropriately staffed to ensure timely completion of responsibilities
- Demonstrated effective knowledge and use of various computer systems.
- Additional responsibilities as assigned
- Ability to travel 10%
- Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience.
- Master’s degree in business or leadership preferred
- 5-10 years of experience in a highly regulated industry, preferably medical devices, required
- Experience with document management systems required
- Experience with Atlassian Confluence and JIRA preferred
- Knowledge of supplier qualification activities required
- Knowledge of GMP required
- Experience with MS Office Products required
- Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required
- Ability to work independently and lead and mentor others required
- Demonstrated strong attention to detail and “do it right the first time” attitude required
- Good judgment and decision-making skills are required (knows how to make trade-off decisions while balancing compliance and business impact)
- Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required
- Knowledge of EU MDR requirements preferred
- Experience with Design Quality responsibilities preferred
- 1-2 years of auditing experience preferred
- ASQ Quality Certification preferred
- Experience with ISO-14971 and associated Risk Management Processes preferred
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.