VP, Regulatory Affairs & Quality
Title: VP, Regulatory Affairs & Quality Assurance
Location: Wilsonville, OR or SSF, CA (on-site)
The VP, Regulatory Affairs and Quality Assurance will be a key member of the senior leadership team, responsible for overall management of Quality and Regulatory activities in support of the Twist Bioscience’s growth objectives. In addition to their externally-facing activities, they will play an important role collaborating cross-functionally with Product Development, Marketing, Manufacturing, Legal and certain strategic outside partners. The head of RA/QA will be a key leader in enhancing and developing the organizations RA/QA capabilities and qualifications to enable strategic initiatives.
What You’ll Be Doing
- Development, implementation, maintenance and overall success of the
company’s regulatory affairs and quality assurance strategy & programs; including
establishing quality standards/metrics/objectives, developing methods to embed quality
into the product development and manufacturing process, establishing supplier
relationships and quality standards and developing and implementing innovative
programs to focus employees on improving product quality.
- Implementing 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 commercialization.
- Building and managing relationships with FDA and global regulatory agencies and standards groups.
- Defining and implementing regulatory strategies and submissions in support of new and existing products as relevant.
- Developing and maintaining current regulatory knowledge and staying abreast of regulatory procedures and changes, interpreting regulations, providing regulatory insight, advice and support to other functions.
- Coordinates internal and external quality audits and preparation of audit reports, corrective action plans and follow up updates.
- 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.
- Implement, monitor, and promote best practices of Quality Management
Systems to ensure compliance with relevant FDA, EU, and global
- 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.
- Develop and manage department and study-specific budgets.
Key Skills and Experience
- The VP RA/QA will be analytical, results and process oriented by nature, detail driven, possesses strong interpersonal skills, and have a desire and passion for quality and regulatory compliance.
- Excellent working knowledge of the US and global regulatory framework and their relevant governing authorities with direct experience handling submissions [e.g., PMA, 510(k), CE Marking].
- Direct experience with FDA Quality System Regulations and ISO 13485 regulatory requirements and implementation.
- Extensive experience in preparing and leading engagements directly with regulatory agencies. Ability to coach others to do the same.
- A commercial focus in the application of regulatory requirements.
- Outstanding communication skills, both verbal and written, and the ability to interface effectively across key functional areas.
- Strong conceptual, analytical, and problem-solving abilities.
- Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects, and meet deadlines.
- Proven experience in leading change management initiatives through periods of rapid expansion.
- Working knowledge of multiple business functions, including operations, quality, logistics, finance, sales, customer service, engineering, IT, and human resources.
- Ability to travel based on business needs, typically 10-20%, but flexing higher when needed.
● Bachelor’s degree in relevant area of engineering or scientific discipline. Advanced degree (MS or PhD) is strongly preferred.
- At least 10+ years of progressive related experience leading RA/QA in a life sciences company.
- Experience with in vitro diagnostics, 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