VP, Regulatory Affairs & Quality

Title: VP, Regulatory Affairs & Quality Assurance

Location: Wilsonville, OR or SSF, CA (on-site)

About Twist Bioscience

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.

The VP, Regulatory Affairs and Quality Assurance is responsible for leading and implementing
strategic and operation day-to-day regulatory and quality activities for Twist Bioscience’s
portfolio. Individual will be responsible for the regulatory plans and the development of current
and future indications as well as leading all present and future quality assurance responsibilities
for the organization. Individual will also play an important role in maintaining effective
communication and constructive working relationships with both internal and external
collaborators including regulatory consultants under contract and regulatory authorities globally.
These activities include acting as the management representative and regulatory representative.
Individual will develop and implement strategies for timely submission and approval of pre-
clinical submissions, applications for clinical trials, marketing applications, etc. Provides counsel
to and manages the regulatory team. The Sr. Director will work closely with members of the R&D
team, Product Development, Legal, interact with regulatory agencies, and ensure timely
preparation of scientifically valid submissions.

What You’ll Be Doing

● Responsible for development, implementation, maintenance and overall success of the
company’s regulatory affairs programs & strategy and quality assurance; including
establishing quality standards/metrics/objectives, developing methods to embed quality
into the product development and manufacturing process, establishing vendor
relationships and quality standards and developing and implementing innovative
programs to focus employees on improving product quality.
● Implement process improvements required to ensure GxP compliance in early clinical
development environment with strategic view to grow Quality function as the products
advance to late-stage development and potential commercialization.

● Liaise directly with FDA and other regulatory agencies, including the preparation and
leading agency meetings.
● Create and execute a plan for ensuring a state of inspection readiness and continuous
improvement.
● Incorporate a global regulatory strategy into GxP compliance policies, regulatory filings,
supply chain operations, marketing sales and external partnerships.
● Ensure adequacy of departmental and company standard operating procedures (SOPs)
from a GxP perspective.
● Oversee global regulatory strategy and submissions in compliance with all applicable
global regulatory requirements and in alignment with corporate goals.
● Serve as the company representative for the FDA and other relevant external
stakeholders, including Twist Biopharmaceutical partnerships.
● Ensure supplier quality objectives are met
● Provide strategic and technical leadership of Quality Assurance activities and deliverables
in support of the product pipelines.
● Collaborate with senior management and all functional groups at all levels of the
enterprise to drive a culture of Quality by conceiving, collaborating, and supporting the
implementation of specific actions, processes and behaviors that support such a culture.
● Collaborate with clinical affairs and R&D teams to develop regulatory strategies which
accelerate time to market.
● Implement, monitor, and promote best practices of all Quality Assurance/Management
Systems to ensure compliance with relevant FDA, EU, and global
regulations/directives/requirements and ICH guidelines.
● Implement a CMC (chemistry, manufacturing, and control) strategy on the quality function
via objectives and plans to ensure quality oversight, timely resolution of issues and early
intervention to assure compliance.
● Identify, resolve, or escalate any and all product, process or customer Quality-related
issues that pose risk with respect to the patient, customers or compliance.
● Work with and contribute to managing external regulatory and QA related CROs and
vendors to drive excellence and meet pha