Quality Assurance Manager
Durham, NC
Quality /
Full-Time /
On-site
Xilis, Inc. is an innovation-driven biotech company developing its proprietary MicroOrganoSphere (“MOS”) Technology for functional precision oncology. Xilis’ MOS Technology enables rapid and scalable generation of patient tumor models that retain patient-specific tumor biology and tumor microenvironment, representing one of the most translationally-relevant ex vivo technologies for precision oncology drug discovery and development. Located in Research Triangle Park, Durham, NC, Xilis is building a functional precision medicine platform that incorporates scaled multi-modal profiling of therapeutic activity and AI/ML-enabled analytics to catalyze functional precision medicine drug discovery, development and diagnostics. Collectively, Xilis aims to harness its MOS Platform to enable development of the most effective therapeutics and guide them to the right patients at the right time.
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. For this role, we require previous experience developing and implementing Quality programs and initiatives as well as developing and delivering training of Quality programs.
Responsibilities
- 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 employees on quality program requirements, standard operating procedures, and industry best practices.
- 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
Requirements
- 5+ years of experience working in the biotech or pharmaceutical industry; preferably with CLIA experience
- Must have experience developing and implementing Quality programs and initiatives.
- Must have experience developing and delivering training of Quality programs.
- 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!).
