Senior Director of Quality Assurance Analytical
As the Senior 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.
How you’ll contribute:
- 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.
What you’ll bring:
- Minimum of a Bachelor and/or advanced degree in a life science field
- Minimum of 10 years experience in quality management systems in the FDA regulated domain - IVDs or medical device
- Minimum of 7 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
Freenome has adopted a COVID-19 vaccination policy to safeguard the health and well-being of our employees. As a condition of employment, our employees working on-site are required to be fully vaccinated for COVID-19, unless a reasonable accommodation is approved or as otherwise required by law.
Freenome is on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent cancer.
We have pioneered the most comprehensive multiomics platform for early cancer detection through a routine blood draw. By combining deep expertise in molecular biology with advanced computational biology and machine learning techniques to recognize disease-associated patterns among billions of circulating, cell-free biomarkers, we are developing simple and accurate blood tests for early cancer detection and integrating the actionable insights into health systems to operationalize a machine learning feedback loop between care and science.
Our recent $270 Million Series C brings our financing to over $500 million from investors, including; Bain Capital, Perceptive Advisors, RA Capital, Polaris Partners, Andreessen Horowitz, funds and accounts advised by T. Rowe Price Associates, Inc., GV (formerly Google Ventures), Roche Venture Fund, Kaiser Permanente Ventures, American Cancer Society’s BrightEdge Ventures, Data Collective Venture Capital, Novartis and Verily Life Sciences.
Freenome is building technology to advance the understanding of cancer through multiple analytes derived from blood. These signals include cell-free DNA, methylation of cell-free DNA, cell-free RNA, circulating proteins, and immune profiling derived from thousands of prospective samples. By developing novel statistical learning methods and applying them to integrate various -omics datasets, Freenome is a leader in modeling specific biological mechanisms to capture disease-dependent signatures, including gene expression, immune response, tumor burden, the tissue of origin, and 3D chromatin structure.
By building comprehensive discovery datasets and modeling critical biological systems, Freenome is learning what biological changes are present within the blood between a variety of different disease states, including cancer, autoimmune disorders, infections, drug response, and aging. The synthesis of Freenome’s datasets, cross-functional technical expertise, and audacious mission to discover biological truth, we seek to improve the lives of millions through early detection and early treatment of disease.
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.
We value empathy, integrity, and trust in one another, and we respect the diverse perspectives of our colleagues and those we serve. We assume positive intent and give each other the benefit of the doubt with the firm belief that we are a team working toward the same objectives. We believe in empowering and supporting each other in a collaborative and dynamic environment.
What does a successful person look like at Freenome?
Those who thrive at Freenome prioritize, manage, and execute their own goals with ownership and alignment with those of the company. They embrace our values of empathy, integrity, striving for greatness, servant leadership, trust, and holding themselves and their team accountable to these values. They crave collaboration with brilliant minds from disparate fields of study and believe that hiring and mentorship are fundamental to our success. Above all, they welcome and provide constructive feedback and criticism, trusting in others’ good intentions, and being secure in knowing that embracing mistakes is the best way to learn and grow. For those who pursue challenges, understudied problems, and want the opportunity to see their work impact the lives of millions of people affected by cancer every year, there’s no better place to be than Freenome.
Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.