Adela is focused on the detection of cancer and other high-morbidity, high-mortality conditions through a blood test. The Company’s genome-wide methylation analysis technology has the unique ability to distinguish the most highly informative (methylated) regions of the genome from the non-informative regions and preferentially target those informative regions for sequencing. The technology is initially being developed for use across the cancer continuum for detection, diagnosis and management and in the future will be applied to other conditions beyond cancer.
Summary:
Under the direction of the VP, Quality and Regulatory, the Director, IVD QA will be responsible for the development of a Quality Management System to support the design, development, and commercialization of clinical testing services and IVD products. The Director, IVD QA will ensure the QMS meets all compliance requirements as defined by global regulatory authorities and will be responsible for implementation and maintenance of the QMS across multiple IVD product development efforts.
Position Responsibilities and Essential Duties
• Develop, maintain, and execute a Quality Management System (QMS) to cover all aspects of IVD product development and commercialization.
• Ensure that Adela’s Quality System meets appropriate US and international standards and regulations for research, development, and commercialization of IVDs.
• Serve as a subject matter expert regarding IVD quality requirements for the company.
• Develop short and long-term quality plans and strategies that support IVD product development processes, and commercialization.
• Partner with cross functional teams in R&D, marketing, clinical, regulatory, and operations to implement quality and regulatory strategies and plans.
• Contribute to the establishment of a strong culture of quality at Adela – lead discussions and training around IVD quality requirements and motivate the organization to want to partner with Quality.
• Align the Quality Management System with Design Control requirements as described in FDA 21 CFR 820 and ISO 13485.
• Review IVD design control documentation to ensure compliance with regulatory requirements.
• Lead quality audits targeting 21 CFR 820 and ISO 13485 compliance.
• Generate and review records of internal audits to ensure compliance with IVD regulatory requirements.
• Serve as Adela’s representative during external IVD quality audits and inspections from external partners and regulatory authorities.
• Contribute to the on-time initiation and closure of Deviations / Investigations, NonConformances, CAPAs, Change Controls with thorough & standardized supporting documentation.
• Contribute to quality procedures and processes for supplier quality, including qualifications, audits, etc.
• Implement and manage quality procedures and processes for clinical development, including cGCP. Required Skills
• Demonstrates skill at multi-tasking and resourcefulness. Ability to participate simultaneously in multiple projects efficiently.
• Demonstrates skill at managing by influence and completing tasks through others in non-reporting relationships.
• Strong analytic & problem-solving ability.
• Proficiency with utilization and management of electronic Document Control Systems.
• Ability to work collaboratively across all functions within the organization.
• Excellent written and verbal communication skills are required.
• Demonstrated results at both a strategic and hands-on level in managing pre- and post approval QA relationships.
• Responds effectively to inquiries or complaints from customers, regulatory agencies, or internal sources
Education and Experience
• BS or higher in Biological Science, Medical Technology, or related field.
• Minimum of 6 years of IVD Quality Assurance management.
• Experience managing quality requirements associated with software lifecycle management (e.g., ISO 62304).
• FDA and ISO 13485 experience required.
• Expert building and maintaining IVD quality management systems.
• Experience working in a blended QMS environment that covers clinical testing and IVD manufacturing – CLIA/ISO/FDA
• Knowledge and understanding of global IVD regulations and guidelines.
• Experience interfacing with regulatory agencies.
• Familiarity with Next Generation Sequencing platforms and workflows preferred.