Director, Quality Assurance (Analytical)
Freenome is a high-growth biotech company on a mission since 2014 to create tools that empower everyone to prevent, detect, and treat their disease.
To achieve this mission, Freenome is developing next-generation blood tests to detect cancer in its earliest, most treatable stages using our multiomics platform and machine learning techniques. Our first blood test will detect early-stage colorectal cancer and advanced adenomas.
As the Director, Quality Assurance (Analytical), you will lead the development and implementation of quality strategy and work in partnership with key functional partners to support development, regulatory approval, and commercialization activities, focused especially on multiomic analytical platform of Freenome’s multiomics platform.
For this role we are seeking someone with strong leadership experience in quality management systems in the FDA regulated domain, IVDs or medical device as well as worldwide regulatory submissions and approval experience in the area of in-vitro diagnostics (IVD) and assay development, particularly Molecular Technologies, automation of laboratory methods, and laboratory information systems.
- Collaborate closely and effectively with development and clinical laboratory colleagues to ensure end to end oversight of Quality operational and technical activities so that plans are created, assessed, reviewed and issues mitigated as appropriate
- Partner with cross-functional and Quality teams to develop and implement policies and procedures fit for purpose quality systems that support design control requirements and regulatory submissions
- Ensure adequate alignment with overall quality and operational policies necessary for technical transfer of analytical methods
- Ensure adequate execution and quality oversight of programs vital for both in vitro diagnostic and clinical laboratory operations
- Lead the risk management processes as related to assay development under design control
- Drive a culture of solution-oriented and evidence-based mind-set with openness for innovative ways of working and appropriate for new analytical methods. Implementing strategic and tactical plans to drive sustainable improvement.
- Ability to interact with all levels of colleagues to ensure in vitro diagnostic methodology and quality management systems are appropriately followed and documented to meet the requirements of technical development and user inputs
- Provide QA leadership/mentorship for assay development, validation, patient enrollment, sample analysis activities, and collection and/or review of regulatory documents.
- Provide key support for any audit activities related to the analytical assay development
- Support Regulatory Affairs in providing quality content and review of documents supporting regulatory submissions to Health authorities globally.
- Lead and/ or support compilation, articulation of corrective actions, facilitation of metrics, and ensure adequate oversight of resolution of quality issues.
Your background, perspective and experience:
- Minimum of a Bachelor and/or advanced degree in a life science field
- Minimum of 8 years experience in quality management systems in the FDA regulated domain - IVD medical devices
- Minimum of 4 years of direct report management
- Experience with worldwide regulatory submissions and approvals in the area of in-vitro diagnostics (IVD) and assay development, particularly Molecular Technologies, automation of laboratory methods, and laboratory information systems
- Broad experience within QMS implementation, and developing new quality policies and procedures. In addition to 21 CFR § 820, experience with ISO 13485, 15189, IMDRF Guidance, CAP, CLIA, NYSDOH is preferred
- A strategic problem solver, with the capability to interact cross divisional and manage day-to day- operations of the group through leadership and effective interaction/influential skills
- Must be able to work in a biohazard environment and follow safety policies and standards outlined in the Safety Manual
As a condition of employment, you agree to know and comply with our COVID-19 vaccination policy requiring all employees who work on-site and/or attend work-related events to be fully vaccinated and to receive a COVID-19 booster once eligible. Company employees working on-site are required to be fully vaccinated for COVID-19 and to receive a COVID-19 booster once eligible, unless a reasonable accommodation is approved or as otherwise required by law. Absent a reasonable accommodation or legal exception, you agree to provide proof of your vaccination status and to be fully vaccinated by your first day on-site, in accordance with our policy. If you are currently eligible for a COVID-19 booster, you also agree to provide proof of having received a booster. If you are not yet eligible for a COVID-19 booster, you must provide proof of receiving a booster within two weeks of becoming eligible.
Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
We have raised more than $1.1B from leading investors including Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis and the American Cancer Society’s BrightEdge Ventures.
A ‘Freenomer’ is a mission-driven employee who is fueled by the opportunity to make a positive impact on patients' lives, who thrives in a culture of respect and cross collaboration, and whose work makes a significant impact on the company and their career.
Freenomers are technical, creative, visionary, grounded, empathetic and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time.
Benefits include but are not limited to:
- Competitive compensation
- Pre-IPO equity
- Flexible PTO (exempt) and generous PTO (non-exempt)
- Comprehensive health coverage, including medical, dental, and vision
- Wellness and mental health resources, including Employee Assistance Programs (EAPs), Paid maternity and paternity leave
- 401(k) plan
- $250.00 new hire stipend to enhance your home office experience
- Plus, a variety of other perks, including pre-tax commuter benefits, two paid volunteer days per year, pet insurance, and additional discounts
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