Sr. Manger / Manager Quality Assurance

Job Description - Sr. Manager / Manger Quality Assurance 

Harbinger Health, a Flagship-founded company, is pioneering early cancer detection. Harbinger aims to detect cancer, at the earliest stages, to save lives. Our platform leverages proprietary biological insights and artificial intelligence to enable high-resolution, molecular views on cancer from blood. We are a highly dynamic, entrepreneurial, and innovation-driven organization seeking collaborative, passionate, and dedicated people to join our team.

Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $200 billion in aggregate value. To date, Flagship has deployed over $2.5 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 42 transformative companies, including Axcella Health (Nasdaq: AXLA), Codiak BioSciences (Nasdaq: CDAK) Denali Therapeutics (Nasdaq: DNLI), Evelo Biosciences (Nasdaq: EVLO), Foghorn Therapeutics (Nasdaq: FHTX), Indigo Ag, Kaleido Biosciences (Nasdaq: KLDO), Moderna (Nasdaq: MRNA), Omega Therapeutics (Nasdaq: OMGA), Rubius Therapeutics (Nasdaq: RUBY), Sana Biotechnology (Nasdaq: SANA), Seres Therapeutics (Nasdaq: MCRB), and Sigilon Therapeutics (Nasdaq: SGTX).

Position Summary

Harbinger Health is looking for a highly motivated Clinical Lab QA Manager/Sr. Manager to join our fast-growing team to support the launch of our early cancer detection platform. This role will report to the Sr. Director of Quality Assurance to support the implementation and ongoing maintenance of the Quality Management System (QMS) for genetic testing of patient specimens based on Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) and New York State CLIA laboratory requirements.

Key responsibilities

• Supports the implementation and maintenance of the QMS in accordance with CLIA, CAP and New York state CLIA laboratory requirements. Creating/implementing QMS procedures/processes as needed.
• Provides ongoing quality support on the daily operations of the clinical laboratory for genetic testing of patient specimens.
• Monitors and supports Clinical laboratory Proficiency Testing as needed.
• Monitors and supports the competency assessment of all Clinical laboratory personnel as needed.
• Coordinates the Quality System Management Review (QSMR). Hosts monthly QSMR meetings and prepares minutes for approval by the laboratory director.
• Performs Quality review/approval of quality records include but not limited to validation protocols and reports, change controls and procedures, CAPAs, NCRs, equipment maintenance records, Laboratory test records and logbooks.
• Monitors changes to applicable regulations and ensure policies and procedures reflect current regulatory requirements. Escalates/communicates quality/compliance issues to upper management.
• Develops and delivers training materials related to Clinical laboratory processes and Quality systems processes and procedures. Conducts New Hire Quality orientation as needed.
• Performs internal audits and supplier quality audits and supports/hosts external inspections.

Qualifications

• At minimum bachelor’s degree in science or other relevant field. MS, MBA or CLS certification a plus.
• Minimum of 5 years of experience in a clinical laboratory for Diagnostic genetic testing.
• Minimum of 3 years of experience in Quality Assurance in a Clinical Laboratory for Diagnostic genetic testing.
• In-depth knowledge about CLIA, CAP and state specific regulations for high complexity diagnostic genetic testing.
• Demonstrated success/experience in managing CLIA, CAP and state Health Department inspections.
• Ability to work in a fast-paced environment and maintain quality standards required for a clinical laboratory.
• Experience with complex life science systems and assays, including automated systems preferred.
• Demonstrated analytical problem-solving skills.
• Strong technical writing and verbal communication skills.
• Strong organizational skills, task oriented, and excellent time management skills.
• Ability to multi-task; flexible and adaptable to changing priorities.
• Attention to details and a strong commitment and passion for quality.
• Proficiency with MS Windows and MS Office tools.
• Knowledge about next generation sequencing is a plus.