Director/Senior Director of Quality
At PrognomiQ, we aim to develop and commercialize transformative tests for early detection and treatment of cancer and other complex diseases. To accomplish this, we are leveraging leading proteomics technology, including the Proteograph product suite from Seer Bio, in combination with other multi-omics assays to develop unprecedented molecular views of health and disease. We are a team of experienced and accomplished scientists supported by a group of leading investors in healthcare and technology.
Would you like to be at the leading edge of molecular data generation and analyses that changes how cancer and other complex diseases are detected and treated? Or are you looking to bring innovative and disruptive solutions to market? If you answer “yes” to either of these questions, let us know by applying!
In this leadership role as the Director/Senior Director of Quality, you will report directly to the COO and be responsible for the overall company strategy for quality and compliance, along with the development and maintenance of the quality systems required to support the development of multi-omics products at PrognomiQ
- Build Quality capability, provide technical leadership and introduce best practices
- Establish and maintain a quality system in compliance with (CAP/CLIA, FDA, QSR) regulations and support product development, document management and training
- Work with senior management to establish the strategic goals of the Quality System
- Report the performance of the Quality Management system to the Executive Management team
- Lead quality design and development activities, continuous improvement activities, development and reporting of KPIs
- Lead quality operations including investigation, risk assessments/management, audits and GMP training
- Provide expertise on data protection regulations and standards
- Support internal and external audits
- Manage supplier selection, agreements, audits and compliance
- Procure and supervise outside vendors and consultants as required
- Develop and administer department budgets, schedules and other administrative functions
- Manage personnel, including organizing and prioritizing team deliverables, writing performance reviews and developing long term employee engagement plans.
- 5+ yrs experience working on products in Medical device or Diagnostics or Clinical Chemistry or Drug development space
- 5+ yrs managing technical professionals within Quality assurance and/or compliance role in medical or pharmaceutical industry
- 5+ yrs of audit experience and good understanding of CAP/CLIA, NYSDOH, FDA regulatory requirements
- Experience serving as domestic and international management representative for interactions with business partners and regulatory agencies
- Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
- Comfortable working in a dynamic start up environment
Equal Opportunity Employment
PrognomiQ is an equal opportunity employer that celebrates diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other characteristic protected by law. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.