Vice President, Regulatory & Quality

Описание вакансии

At Adaptive, we’re Powering the Age of Immune Medicine.Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.

As an Adapter, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application.

It’s time for your next chapter. Discover your story with Adaptive.

Position Overview

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, and ensuring those objectives drive the achievement of company goals. Providing thoughtful coaching and consistent feedback to your team members will drive performance excellence and accountability, as well as support your team members’ growth and development. Leaders at Adaptive create an environment of belonging, respect, and open and honest communication every day.

Key Responsibilities and Essential Functions

Senior Leadership

• 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.

Regulatory Affairs

• 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.

Quality Assurance & Compliance

• 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.

Position Requirements (Education, Experience, Other)

Required

• 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.

Working Conditions

• Work is performed in an office environment.

#LI-Remote

Compensation

Salary Range: $261,000 - $391,600

Other compensation elements include:

• equity grant
• bonus eligible

ALERT: Malicious groups posing as Adaptive employees have recently used fraudulent email aliases to extend employment offers, provide fake documents, and request sensitive personal and financial information. Legitimate Adaptive employment opportunities are initiated through our careers page and extended after multiple interviews with verified employees. Adaptive does not ask new hires to purchase anything out-of-pocket, including home office supplies and equipment.

Interested in this position, but don’t meet all the requirements?  Adaptive is committed to building diverse, equitable, and inclusive teams across our organization.  Please consider applying even if your experience doesn’t match all the qualifications; you may be the exact candidate we’re searching for!

Adaptive is not currently sponsoring candidates requiring work authorization support for this position.

Adaptive’s posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate’s ability to meet minimum qualifications (skills/experience/education), a candidate’s ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives.

Adaptive's benefits at-a-glance.

Adaptive Biotechnologies is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Please refer the “Know Your Rights: Workplace Discrimination is Illegal” Poster for more information. If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email hr@adaptivebiotech.com.

If you have a disability and you believe you need a reasonable accommodation to search for a job opening or to submit an online application, please e-mail accommodations@adaptivebiotech.com. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.

NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners who have active agreements with Adaptive. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.