Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world's leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. Learn more about us at biodesix.com.
OVERVIEW
The position will have broad and critical responsibilities that include:
Responsible for execution of the Internal Audit program at Biodesix, including planning, scheduling, and organizing activities to confirm adherence to internal procedures at all Biodesix sites.
Verifying compliance to the Company's (all sites) Quality Management System (QMS) to comply with all governing regulatory bodies such as CLIA, New York State CLEP, College of American Pathologists (CAP), ISO 13485 and FDA Quality Management System Regulations/GMP.
Ensuring entire company complies with its governing regulatory requirements as well as internal policies and bylaws.
Working with management and staff to identify and manage regulatory risk by ensuring the QMS has internal controls that adequately measure and mitigate.
JOB LOCATION
Louisville, CO - On-Site
REGULATORY REQUIREMENTS
This role shall comply, at a minimum, with the responsibilities outlined in:
CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493
CAP: College of American Pathologists (CAP): All Common, General, Chemistry, Director Responsibility and Authority and all test-specific checklists
FDA: 21 CFR 820/QMSR/GMP
NYS CLEP: New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP), New York State Public Health Law, Article 5 Title 5
ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016
All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD
Other international regulatory agencies as applicable
RESPONSIBILITIES
Responsible for Internal Audit System for all site Quality Management Systems, conducting all audits per governing regulatory requirements and ensuring all findings are accurately and efficiently resolved in a timely manner.
Act as lead auditor, support auditor, or resource to other auditors.
Conduct audits, investigations and reviews of data sources outside of the internal audit schedule when necessary.
Work directly with manager to provide timely communication of audit status.
Determine or assist in determining the objective, scope, and general plan of the assigned audit.
Ensure the existence of appropriate documentation by the preparation of work papers that adequately summarize the test work performed, observations made, and conclusions reached.
Prepare the timely draft of the audit report that clearly states the audit scope and findings in accordance with Professional and departmental standards.
Evaluate audit responses for adequacy, including root cause, timeliness as well as utilizes knowledge to facilitate appropriate corrective action.
Assist and participate in the execution of site based external regulatory audits at Biodesix sites.
Assist with the preparation of external regulatory audit responses to observations, as requested.
Support and participate in inspection readiness workstreams and remediation activities, as applicable, to ensure site is inspection-ready at all times.
Support evaluations to ensure appropriate site policies, procedures, and documentation are in place to support Quality Systems according to applicable regulatory requirements.
Prepare metrics and summaries to effectively communicate status and recommendations to Senior management.
REQUIREMENTS
Externally certified to conduct internal audits per ISO 13485:2016 or willing to obtain prior to start date.
Excellent analytical and problem-solving skills.
Impeccable communication, presentation and interpersonal skills.
Strong data mining and metric presenting skills.
Able to travel out-of-state
Must be detail-oriented and possess strong organizational and time management skills with the ability to prioritize and manage completion of multiple tasks/projects, communicating when necessary with company personnel to execute.
Able to identify short term, intermediate, and long term issues, and be able to appropriately resolve conflict and prioritize work, as necessary.
A motivated self-starter able to perform the required responsibilities with minimal direction.
Ability to work as part of internal and remote teams with a strong understanding and appreciation of other department/personnel's work disciplines.
Strong research and regulatory interpretation skills.
Ability to apply requirements fit for purpose of the regulatory environment.
Drive process efficiencies and improvements.
Concise, decisive, and communicative
EDUCATION AND EXPERIENCE
Bachelor's or advanced degree preferred; equivalent work experience will be considered.
Minimum of 2 years' related industry experience
Clinical laboratory experience preferred, as it relates to commercializing a laboratory developed test in a CLIA laboratory with an ability to understand the complexities involved with in vitro diagnostic multivariate index assays.
Experience in a regulated environment and knowledge of ISO 13485, CLIA/CAP and NYS CLEP regulations and standards desired.
Strong proficiencies with computer skills, Microsoft Office, Microsoft Excel, Microsoft Outlook, PowerPoint, etc.
COMPENSATION
We are excited to provide
Annual Base Salary Starting at $60,000
Reimbursement for ASQ / BSI Internal Auditor Certification
Discretionary Bonus opportunity
Comprehensive health coverage: Medical, Dental, and Vision
Insurance: Short/Long Term Disability and Life Insurance
Financial benefits: 401(k), Flex Spending Account
120 hours of annual vacation
72 hours of paid sick time off
11 paid holidays + 3 floating holidays
Employee Assistance Program
Voluntary Benefits
Employee recognition program
Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.
Biodesix is 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, disability, or veteran status.