Director, Quality Assurance
Reports to: Chief Executive Officer
This position is responsible for maintaining the Quality Assurance function and for defining the overall quality strategy to ensure achievement of overall commercial and corporate objectives. Serving as the Quality Management Representative, this position is responsible for providing input to the design, and monitoring of, the implementation and maintenance of Biotheranostics’ Quality Management System for compliance with CLIA regulations (42CFR493), College of American Pathologists (CAP) checklists and applicable state requirements. This position will interface with cross-functional departments to facilitate adherence to system requirements and resolution of events. As a senior leader, this individual must effectively lead and mentor teams.
- Establishes the Quality Assurance function to ensure achievement of overall commercial and corporate objectives.
- Creates mechanisms for accountability and metrics tracking to develop and to ensure a Quality Assurance corporate culture aligned with overall commercial and corporate objectives.
- Ensures the recruitment, retention, training, development and performance management within the Quality Assurance Department.
- Ensures employee relations and the development of a team-oriented culture within and between departments.
- Continually assesses quality operations in light of corporate strategies, the Company’s Corporate Compliance Program, and identifies improvements.
- Develops and maintains budgets and planning for the Quality Assurance function.
- Serves as Quality Management Representative and participates in efforts to define and execute creation of a unified Quality Management System in compliance with CLIA, CAP, state specific laboratory requirements, LDT oversight and Corporate Compliance Program Policy to ensure attainment of corporate business objectives and sustainability of delivering quality product.
- Assists the efforts of the CLIA laboratory to investigate and resolve quality incidents as appropriate. Ensures that Quality Assurance documentation of such events including incident reports, complaint files, investigations, corrective action and preventive actions (CAPA) meet the standards described in the Quality Management Plan
- Conducts and/or supports Laboratory Quality Management Reviews and Executive Quality Management Reviews.
- Oversees maintenance of current federal and state clinical laboratory accreditations, licenses, certifications and permits.
- Serves as a key resource to support quality education and risk mitigation for the organization (e.g., root cause investigations and corrective and preventive actions).
- Leads cross-functional teams to develop and to improve systems to increase efficiency of quality processes.
- Manages and mentors Quality Assurance resources to support talent development and utilization in alignment with the operating plan.
- Provides routine updates and communications to the Compliance Officer, General Counsel and other members of the executive team and company-wide, as needed, to ensure transparency and awareness of progress towards meeting corporate business objectives
- Leads third party quality and supplier audits and inspections.
- Provides site training on quality processes.
- Other duties as assigned.
- BA or BS degree required in life sciences, physical sciences, engineering, or other applicable technical field
- MS in Business Administration, or advanced training in quality systems preferred
- Knowledge of LDTs in a CAP accredited and CLIA certified laboratory
- A minimum of 5 years in Quality Assurance/Systems for the design and production of LDT products in a CLIA laboratory
- ASQ Certification or equivalent experience
- Advanced knowledge and ability to apply CLIA, CAP, ISO and other applicable regulations
- Proven ability to develop and implement quality systems in compliance with CLIA
- Strong aptitude for troubleshooting and resolving issues through collaboration and clear communication with executive team members and others
- Ability to lead functional areas and extended project teams
- Strong commitment to detail and error-free performance with ability to multi-task
- Self-starter and able to work with minimum supervision
- Excellent verbal and written communication skills and presentation abilities.
If interested, please submit a copy of your CV/Resume to us to apply.E-mail