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 to 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 Quality Assurance Manager. 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

• Manage document and change control processes and acts as system administrator for company’s electronic Product Lifecycle Management
• Maintain company policies/procedures and determine company needs to comply with local, state and federal regulations
• Ensure organization is audit ready (FDA, CLIA, CAP, ISO, CMS and partnership due diligence audits)
• Participate in several LDT test development and launch activities
• Support development and implementation of interdepartmental processes to ensure compliance to regulated QA activities for commercial operations

QUALIFICATIONS

• BS in biological sciences, chemistry or analytical chemistry
• >5 years of experience heading quality organizations
• Extensive experience in Document Control and occurrence management (NCR, CAPA and Complaints)
• Proven vendor management/audit/SCAR programs
• Operated in GxP environments and experienced with CLIA/CAP/ISO/FDA audit preparedness and regulatory filings
• Proven product design and launch in the healthcare industry (RUO/LDT/FDA)
• Risk management and strategic analysis is a must
• A genuine desire to impact patient lives