Quality Assurance Specialist

Xilis, Inc is a Duke spinoff founded by Duke professors David Hsu (M.D./Ph.D) and Xiling Shen (Ph.D) in Durham, North Carolina. The company has been developing cutting-edge Patient-Derived Micro-OrganoSpheres (MOS) technology for precision cancer diagnostics and drug development. Xilis’ transformative platform recreates patient-specific tumors in their 3D and environmental complexity at micro-scale ex vivo, allowing ultra-high-throughput, clinically-relevant, and affordable experimental selection of the safest, most effective drugs for each and every patient in a matter of days. The company aims to transform cancer care by ensuring each and every patient gets treated in a timely manner with the single most appropriate drug available to them. We are supported in this mission by top Silicon Valley and New York venture firms that are leaders in the healthcare space and have invested in top precision medicine companies including Foundation Medicine and Guardant Health. 

Role

 Xilis is looking to hire a Sr. Quality Assurance Specialist to support the further development of the Quality & Compliance programs. This hands-on individual partners across functions to develop and support program development, integration, implementation, and process improvement activities. The primary responsibilities of this position will be to consult with department representatives, project teams, and management to ensure compliance of deliverables and products. As part of the Quality & Compliance team, you will be responsible for developing, maintaining, and executing procedures, overseeing operations, and providing consultation on the implementation of Quality & Compliance programs.

• General administration of company policies and procedures.
• Ensures that the organization operates within established policies/procedures and complies with applicable governmental regulations (GMP, CLIA, EMA, etc.)
• Assist in the development and execution of the quality schedule 
• Develops, maintains, and provides expertise on site quality and/or business systems, tools, data, procedures, and processes on an ongoing basis
• Work directly with Xilis teams to provide process oversight and to support them in their efforts to comply with company standards and regulatory requirements
• Provide expertise and guidance with the interpretation of policies, regulatory requirements, and / or internal processes
• Schedule, plan, conduct, and document internal and supplier audits
• Supports regulatory and customer audit/inspection readiness of the organization; review audit outcomes to ensure appropriate and timely corrective actions are implemented (as applicable)
• Supports the compilation, analysis, and reporting of metrics, including identification of trends and/or root cause to help develop and deploy new initiatives and process improvements
• Uses existing procedures to solve routine or standard problems and uses data to make Quality decisions. Where procedures may not exist, identify compliant solutions and / or develop appropriate procedures.
• Create and maintain risk assessments to ensure program / project risks are identified, assessed, mitigated, and closed.
• Conducts Quality-focused training sessions to educate team members; training may include aseptic practices, deviations investigations, data integrity, quality risk management, and change management.
• Performs quality reviews of technical documents to assure the accuracy, completeness, and clarity of the documents and ensure that documents meet relevant requirements
• Manages, tracks, and reports status of Quality Systems programs including Deviation Management, Corrective Action and Preventive Action (CAPA), Change Control, and Quality Risk Management.
• Support validation activities by creating, contributing, reviewing, and / or approving associated deliverables

• 5+ years of experience working in the biotech or pharmaceutical industry; preferably with CLIA experience
• Experience leading deviation investigations through to root cause and CAPA development
• Prior auditing experience in a regulated environment
• Strong interpersonal communication and time management skills
• Strong written and oral communication skills with the ability to convey information in a clear and concise manner to entry-level staff and executive management
• Highly effective team and interpersonal skills, including the ability to work across scientific disciplines
• Excellent organizational skills and attention to detail
• A flexible attitude with respect to work assignments, tight timelines, and new learning opportunities
• Participation in the development of department goals, objectives, and key performance indicators
• Exceptional analytical and problem-solving skills with the proven ability to think strategically

Xilis was created when its three founders — an engineer, a physician, and a biologist — decided to come together and commercialize their technology to transform cancer care. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We do not discriminate on the basis of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. Furthermore, even if your work experience isn't perfectly aligned with what we've described above, if you're excited about what we're building then we want to talk to you!

Xilis offers comprehensive health, vision, dental & retirement plans, and unlimited PTO. We are a remote-friendly team: our headquarters are in Durham, North Carolina, but we have team members across the US (and beyond!).

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