[Hiring] Vice President, Regulatory & Quality @Adaptive Biotechnologies

Role Description

The VP, Regulatory & Quality will proactively develop, lead, and drive the execution of global regulatory strategy and quality oversight for Adaptive and monitor new regulations and industry guidance to make recommendations to Executive team Heath. As a key leader in the organization, this role is responsible for managing the RA and QA teams to work collaboratively towards defining appropriate regulatory pathways which align with corporate objectives. The VP, Regulatory & Quality leads rapid and timely regulatory plans for Adaptive’s diagnostic products, while advising product development, Medical Affairs, MRD Pharma, Legal, Clinical Lab Operations, Manufacturing and ensuring global regulatory compliance. This position also has responsibility for leading the development, management, and continual improvement of Adaptive’s Quality Management System (QMS).

Leaders at Adaptive demonstrate behaviors consistent with Adaptive’s Core Values and Leadership Principles. Critical functions of your role include:

• Helping establish individual team member goals.
• Aligning those individual goals with broader team objectives.
• Ensuring those objectives drive the achievement of company goals.
• Providing thoughtful coaching and consistent feedback to your team members.
• Creating an environment of belonging, respect, and open and honest communication.

Qualifications

• BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree strongly preferred.
• 20+ years of progressive management experience in global quality assurance and regulatory affairs in a diagnostic, medical device or life sciences technology-driven company.
• Prior experience leading a function or sub-function.
• Experience with product submissions in multiple therapeutic areas (hematology, oncology, immunology) and NGS technology highly preferred.
• Experience in strategic planning and collaboration with executives, key operational groups and external partners.
• Expertise with all phases of the product development lifecycle, including feasibility, design, development, transfer, verification and validation activities necessary for research and diagnostic product commercialization.
• Extensive experience in ISO, CLIA, CAP, CLEP, GxP and other Regulatory compliance requirements.
• Proven hands-on experience in submission and approval of global regulatory filings and reporting for US (510(k)) and other key countries/regions, including CE marks.
• History of successful direct interactions and negotiations with regulatory agencies.
• Experience implementing and managing quality/compliance systems and ensuring inspection readiness.

Requirements

• Work is performed in an office environment.

Benefits

• Salary Range: $261,000 - $391,600
• Equity grant
• Bonus eligible