Vice President, Regulatory, Quality

Role Overview

• Serve as a key and active member of the leadership team, working collaboratively to ensure regulatory and quality objectives are met and aligned with Adaptive’s objectives.
• Lead and mentor the Quality Assurance and Regulatory Affairs, delegating appropriate levels of accountability for decision making and clearly communicating requirements and plans, cross functionally within the organization.
• Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to inform commercialization plans approvals worldwide.
• Provide counsel, training and interpretation of FDA and global regulatory requirements to all company personnel.
• Oversee preparation and filing of all regulatory documents with the FDA, notifying body, and international regulatory agencies, within applicable regulations and guidelines.
• Provide regulatory oversight and guidance for compliant product promotion.
• Develop and maintain external relationships with relevant opinion leaders and regulatory officials including meeting with pharma partners for clinical trial regulatory strategies, interacting with global regulatory agencies for all regulatory submissions, managing relationship with Authorized Representative.
• Work cross functionally with collaborator to support pharma partner regulatory requirements.
• Direct the development of systems, practices and processes to ensure effective ongoing review of product design or other operational and manufacturing changes.
• Provide leadership, direction and oversight to manage deviation events that may impact compliance status or create business risk.
• Responsible for strategic leadership of Adaptive’s Quality Management System (QMS).
• Set, maintain, and train cross functional teams on regulatory policies and quality standards for all quality systems and ensure compliance with applicable regulations worldwide.
• Facilitate management review of Adaptive’s QMS to monitor performance and create/support process enhancement initiatives to drive continuous improvement.
• Drive execution of QMS processes through programs, policies and functions that support corporate and product quality.
• Support specific departmental needs to maintain and improve QMS requirements for ongoing laboratory and other operational activities.
• Collaborate cross-functionally with internal departments on strategy development, risk assessments and implementation of quality principles and regulatory requirements.
• Develop and execute quality design and quality assurance strategy for new product development, changes and improvements.
• In support of the quality system, provide effective leadership support, training and guidance to all company personnel.
• All other duties as assigned.

Requirements

• 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. Advanced degree offsets years of experience (MS + 18 and PhD + 12 years of experience)
• 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.

Benefits

• equity grant
• bonus eligible