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. You 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 phase appropriate regulations and timelines. ● Provide support, mentorship and guidance to regulatory affairs and quality assurance to ensure staff can independently make sound strategic and tactical decisions. ● Develop the technical, GMP and leadership skills of direct reports, including performance reviews. ● Promote continuous improvement and process improvement mindset. ● Serve as the company subject matter expert and advisor on regulatory trends, guidance, and changes. ● Develop and manage department and study-specific budgets. Qualifications ● Bachelor’s degree in engineering or scientific discipline. Advanced degree (MS or PhD) preferred What You’ll Bring to the Team ● At least 10+ years’ experience with Laboratory Developed Tests, diagnostics medical device products, and/or Therapeutics Development including hands-on experience in developing and implementing policies and procedures for Regulatory Affairs and Quality Assurances. ● Expert knowledge of US and global GXP/ISO regulations and guidelines, including industry best practices and standards in regulatory affairs and quality assurance. ● Ability to communicate effectively both verbally and in writing. ● Experience leading CLIA, CAP, FDA, EMA Prime Scheme (Europe Personalized Medicines), BfArM (Germany), MHRA (UK), NMPA (China), PMDA (Japan), KFDA (Korea), COFERPRIS (Mexico), ANMAT (Argentina), INVIMA (Columbia), DIGEMID (Peru), ● Proven track record of successful PMAs, 510ks, IVDD, and NDA filings. ● Strong Regulatory Affairs experience with IVD, Medical Devices, and/or Infectious Disease therapeutic areas. ● Significant experience leading face-to-face and other formal interactions with FDA and other health authorities. ● Solid experience with CMC, clinical, and nonclinical development and Regulatory submissions. ● Ex-US or global regulatory experience highly desired. ● Ability to interact effectively across all levels of the organizations; integrates functional expertise with business knowledge to solve problems, meet priorities and deadlines in alignment with corporate goals and objectives. ● Must be an influential leader who possesses a cross-functional collaborative skill set. ● Regulatory leadership and/or team management experience highly desired. ● Demonstrated proficiency in departmental budgeting, organizing and planning. ● Demonstrated ability to work both independently and in a team environment. ● Excellent oral and written communication skills with strong attention to detail and the ability to coordinate and oversee multiple activities. ● In-depth understanding of In Vitro Diagnostics development, Therapeutics development , product commercialization, and life cycle management processes. ● Strong collaboration, leadership competencies, and strategic business perspectives are required. 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.   #LI-LK1   The base cash compensation for this California-based role is below. In addition to base salary, this role is eligible for bonus, equity, and a generous benefits package. Final compensation amounts are determined by multiple factors, including candidate skill, experience, expertise, and location and may vary from the amount listed above. Compensation may be different in other locations. San Francisco Bay Area Pay Range $225,000 — $310,000 USD