VP, Quality Assurance

    • Job Tracking ID: 180079
    • Job Location: Seattle, WA
    • Job Level: Any
    • Level of Education: Any
    • Job Type: Full-Time/Regular
    • Date Updated: June 14, 2018
    • Years of Experience: Not Applicable
    • Starting Date: ASAP
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Job Description:

ARE YOU ADAPTIVE? We’re driving groundbreaking research in cancer and other immune-mediated diseases that translates into novel clinical diagnostics and innovative therapeutics. We are at the forefront of immune-based discoveries, transforming the future state of health through our disruptive, proprietary immunosequencing technology. With strong financial footing and rapid growth, we are looking for the brightest, most passionate and collaborative innovators to join us.

At Adaptive, you'll be challenged, you'll be inspired, and you'll be proud to be part of an innovative organization making a real impact on improving the quality of life globally. No matter what your role is, you'll find a diverse, team-driven, fun culture where your contributions truly count.

Position Overview

The Vice President of Quality Assurance will proactively develop, lead and drive the execution of Quality Assurance strategy and oversight for Adaptive. This position also has responsibility for leading the development, management and continual improvement of Adaptive’s Quality Management System (QMS).

Duties and Responsibilities

Leadership

  • Serve as a key leader at Adaptive, working collaboratively to ensure Quality Assurance objectives are met and aligned with Adaptive’s operational and regulatory objectives.
  • Lead and mentor the Quality Assurance organization, ensuring appropriate levels of accountability for decision making and clearly communicating cross functionally within the organization.

Quality Assurance & Compliance

  • Responsible for strategic leadership of Adaptive’s Quality Management System (QMS).
  • Set and maintain 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.

Experience and Skills:

Education

  • BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree strongly preferred.

Experience

  • 10+ years of progressive management experience in global quality assurance in a diagnostic, medical device or life sciences technology driven company.
  • Experience in multiple therapeutic areas (hematology, oncology, immunology) and NGS technology highly preferred.
  • Experience in strategic planning and collaboration cross-functionally, including operational, R&D and regulatory groups.
  • Experience 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.
  • Experience implementing and managing quality/compliance systems and ensuring inspection readiness.

Other Skills and Knowledge:

  • High level of personal and professional integrity and trustworthiness with strong work ethic.
  • Excellent communication (written and verbal) and presentation skills.
  • Solid knowledge of and experience in strategic planning, risk management, diagnostic product development and operations.
  • Extensive ability to analyze complex situations and propose practical solutions.
  • Ability to develop and manage a high-performance team focused on accountability and exceeding expectations.
  • Ability to lead, influence, create and work within cross-functional team environments.
  • Assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude and a sense of urgency to get things done.

Salary is commensurate with experience and qualifications. Excellent benefits package including employer paid medical, dental, vision, vacations and holidays for eligible positions.

Adaptive Biotechnologies Corp. is proud to be an 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 on the basis of disability.

NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. 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.