Cross-Functional Quality Specialist

Who we are: At Arkana Laboratories, everyone has an important role to fill. Come join us and be a part of a team dedicated to making life better for those who need it most.

This place is packed with super-smart people who do their best work together. We work hard every day to advance our understanding of disease and provide world-class care to our patients in hopes of leaving our corner of the world a little better than we found it. While we are committed to improving the lives of thousands of patients, we never lose sight of the realization that they are the reason we get to create change in our field.

Built on generosity, teamwork, and the freedom to try new things, we take great pride in our work. Great ideas come from everywhere in this company and we celebrate each success and failure for the opportunity it gives us to keep reaching. For more than twenty years after our founder, Dr. Patrick Walker, wrote his goals on the back of a napkin, our people, culture, and values have remained strong.

About the position: As the Cross-Functional Quality Specialist, you will serve as a pivotal liaison across Clinical Trials, Laboratory Operations, IT, Materials Management, and other departments as needed to advance a cohesive framework for quality, regulatory compliance, and continuous improvement. This role ensures that processes, documentation, systems, and operations comply with regulatory standards, including FDA (21 CFR Parts 11, 211, 820), ISO 13485, GxP, and CAP, while cultivating a culture of continuous improvement, quality, and operational excellence. 

Leveraging comprehensive regulatory expertise, systems thinking, and strong facilitation capabilities, the Cross-Functional Quality Specialist identifies operational risks, leads thorough root cause analyses, and drives the implementation of effective, scalable quality improvements across multiple departments. This position provides critical support for both internal and external audits, manages risk assessments, oversees corrective and preventive action (CAPA) processes, and collaborates closely with departmental leadership to ensure consistent and rigorous execution of quality management practices throughout Arkana.

Beyond traditional compliance oversight, this role functions as a strategic partner and facilitator by translating regulatory requirements into practical, actionable workflows, fostering alignment among cross-functional stakeholders, and enhancing Arkana’s preparedness for organizational growth, innovation, and regulatory evaluation.

What you'll do: 

• Lead and facilitate quality assurance and compliance initiatives across Clinical Trials, Laboratory Operations, IT, Materials Management, and additional teams as required
• Ensure organizational processes, documentation, and systems comply with FDA regulations, GxP standards, CAP guidelines, and other applicable regulatory standards
• Lead and coordinate internal audits and support external inspections, including preparation, documentation gathering, and response management
• Conduct risk assessments across departments, identify operational risks, and collaborate on development and implementation of mitigation strategies
• Lead and support continuous improvement initiatives, applying Lean, Six Sigma, or other methodologies to enhance process efficiency, reliability, and compliance
• Manage and oversee corrective and preventive action (CAPA) processes, ensuring timely investigations, root cause analysis, and verification of effectiveness
• Facilitate root cause investigations using structured problem-solving methodologies and drive resolution of quality issues
• Develop, review, and maintain controlled quality documentation, including SOPs, work instructions, and training materials, ensuring adherence to document control policie
• Collaborate with IT and operational teams to ensure validation, change control, and compliance of computerized systems and digital platforms
• Track, analyze, and report quality metrics, audit findings, CAPA status, and regulatory compliance trends to leadership and stakeholders
• Deliver quality and compliance training, promote awareness, and foster a culture of accountability, transparency, and continuous improvement across the organization
• Partner with leadership and cross-functional teams to support enterprise-wide quality strategies, ensuring readiness for growth, innovation, and regulatory oversight 
• Prepare internal trend analysis of audit observations, addresses audit risks through corrective and preventative actions (internal and external), and identify any compliance risks
• Provide guidance on regulatory compliance to internal clients
• Establish error benchmarking based on relevant industry standards or internal goals