Vice President, Quality Assurance

Organization
BioFire Diagnositcs
Job Location
390 Wakara Way
Salt Lake City, UT 84108
Benefits

BioFire Diagnostics offers a generous 401(k) package with no vesting period. 

 Employees are eligible for full medical, dental, and vision benefits starting on the first day of employment. 

BioFire offers 11 company paid holidays and 4 weeks of paid time off.

Job Description

Position Summary:

 The VP of Quality Assurance collaborates with the CIO to develop BioFire’s strategy to meet FDA, ISO and international Quality Assurance requirements.  The VP of Quality Assurance is responsible for implementing those strategies into our Quality Management System, and is responsible for all QMS continuous improvement activities.  The VP of Quality Assurance acts as the BioFire’s Management Representative.  The VP of Quality Assurance serves on BioFire’s recall committee and interfaces with bioMerieux to ensure global compliance in recalls.  The VP of Quality Assurance acts as BioFire’s liaison to bioMerieux in Quality Assurance matters.

 The VP role works closely with internal business customers, namely the Directors in engineering, biochemistry, software, manufacturing, service, supply chain and regulatory, to align and enable business strategies and to ensure the needs of the company are communicated and met. Communication skills, temperament and ability to collaborate within the company are expected.

 Director-level employees in the QA group report to the VP.  The VP leads a collaborative group and communicates company plans and demands to employees in the group.  The VP participates in hiring and personnel management of the department.  The VP has department budget responsibility.

Principal Job Duties and Responsibilities: 

  1. Perform all work:
    1. In compliance with company policy and within the Quality System.
    2. In close collaboration with company leadership, peers and department directors.
    3. Within the functions defined for the Quality Management Representative
    4. Understanding risks and implementing mitigations for customer and business needs.
  2. Determine strategies to meet FDA, ISO and international Quality Assurance requirements.
    1. Manage the Company Quality function to ensure compliance.
    2. Manage the QMS as a distributed responsibility of every employee at BioFire.
    3. Develop and design quality structures, processes and procedures based on BioFire business needs and expert understanding of quality practice.
    4. Design quality strategies to support business decisions, product applications through the entirety product lifecycle management.
  3. Discuss quality issues:
    1. With company personnel in a collaborative manner that recognizes quality as a partner at BioFire.
    2. Representing the quality system, but gently enforcing the QMS when decisions put the customer or the company at risk
  4. Collaborate with peers and superiors. Keep company leaders apprised of
    1. Quality related issues at BioFire
    2. Expected changes to the quality landscape affecting the company and its products
  5. Build quality teams; assess and develop current and future staff.
    1. Hire and groom an expert team with sufficient background to grow within BioFire.
    2. Train employees to be experts at their role
    3. Grow future quality leadership.
  6. Develop and maintain strong working relationships
    1. With bioMerieux quality, regulatory and legal community
    2. With external legal, regulatory, and quality<strong< strong="">

Principal Decisions:

  1. Changes needed to maintain a compliant Quality Management System
  2. Personnel management for the Quality Assurance Department
  3. Structure and contents of the Quality Management System
  4. External Audit and Inspection preparation and execution
  5. Internal Audit priorities and assignments
  6. Quality Management Review preparation and execution
Requirements

Training and Education: 

Bachelor of Biological Science and Master’s degree in technical or business application.  Experience may be substituted for exceptional candidate or internal candidate.  Additional training is expected in: 

  1. Quality Management System, including 21 CFR parts 7, 11, 806, 820, ISO 13485, 14971 and MDDEV.
  2. GMP manufacturing processes and documentation.
  3. Supply chain quality assurance, including supplier qualification and maintenance
  4. Statistics and data analysis
  5. SAP, desired

Experience:  

Minimum 15 years of experience in Quality Assurance with increasing levels of responsibility.  At least 10 years of experience an IVD environment is required.

About Our Organization

At BioFire, we make a difference, we make the world a healthier and better place. We provide molecular solutions that lessen the time to medical results, empower healthcare professionals to make better diagnostic decisions and lower healthcare costs. We are committed to improving the quality of life for everyone, everywhere, every day.

We surround ourselves with world-class individuals and are committed to a set of principles to build a thriving organization and foster a vibrant community based on trust, integrity and a shared sense of purpose. We reinforce each other’s discipline, creativity and sense of the possible in an exciting environment that is characterized by mutual respect and challenging and fulfilling activity. The diligent and interdependent work of every individual is what makes BioFire exceptional.

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