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May 31, 2019
Location: San Francisco, US

YOU

A Quality professional with proven track record in building, aligning and maintaining quality culture with a maniacal focus on patient experience and outcomes. Everything you do and say leads by example of how quality helps change people’s lives. You don’t see departments, you see individual architects shaking the foundation of science and medicine. If this is you, read on.

US

We are not married to specific tools, technologies or shiny objects. We ask questions until we arrive at the best answer for the patient. We believe glycoproteins are a new language of biology we are translating for the benefit of patients, researchers, science and medicine. We have diverse backgrounds and experiences, skeptical about the status quo yet solution oriented. If this sounds like a good fit, read on.

THE DETAILS

We are seeking a talented individual with proven track record as our Head of Quality/Regulatory. The desired candidates would have experience in FDA, CLIA/CAP and ISO regulations, building a quality culture into every aspect of the organization. Ensuring quality of work and patient centric acumen is a must.

RESPONSIBILITIES

  • Build and manage phase appropriate quality system
  • Develop quality manual, engage management in management review process
  • Lead the charge in rolling out EDMS, calibration, training, CAPA, vendor management and validation efforts
  • Ensure organization is audit ready (FDA, CLIA, CAP, ISO, CMS and partnership due diligence audits)
  • Participate in several LDT test development and launch activities
  • Keep organization up to date on regulatory developments

QUALIFICATIONS

  • BS in biological sciences, chemistry or analytical chemistry
  • >10 years experience heading quality organizations
  • Extensive experience in building and running Quality organizations
  • Proven track record with CLIA/CAP/ISO/FDA audit preparedness and regulatory filings
  • Experience in design control and device history file completion
  • Proven vendor management/audit/SCAR programs
  • Proven product design and launch in the healthcare industry (RUO/LDT/FDA)
  • Operated in all GxP environments
  • Risk management and strategic analysis is a must
  • A genuine desire to impact patient lives
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