Role Overview You will establish and maintain a robust quality culture, ensure ongoing USDA inspection readiness, uphold the highest standards of data integrity and documentation compliance, effectively manage Quality Assurance (QA) and Quality Control(QC) operations, and provide quality leadership that supports the successful delivery of the New World Screwworm programme while protecting regulatory compliance and operational excellence. Key Responsibilities Quality Management System • Develop, review, approve, and maintain quality procedures, policies, and work instructions within the global Quality Management System (QMS). • Ensure compliance with applicable USDA requirements, internal standards, ISO 9001, and industry best practices. • Manage document control processes and ensure documentation remains current and compliant. • Oversee deviation, non-conformance, CAPA, change control, and risk management processes for the site. Quality Assurance Oversight • Ensure production, laboratory, and support operations are conducted in accordance with approved procedures and quality standards. • Review and approve quality-related documentation, investigations, deviations, and corrective actions. • Conduct routine quality audits and inspections of facilities, laboratories, and production areas. • Drive continuous improvement initiatives to enhance quality, compliance, and operational effectiveness. Quality Control Oversight • Oversee QC sampling, testing, monitoring, and data review activities • Ensure environmental monitoring, process monitoring, and quality control programmes are performed effectively. • Review trends and implement actions to address adverse quality indicators • Ensure laboratory equipment, instruments, and systems remain qualified, calibrated, and fit for purpose. Inspection and Regulatory Readiness • Act as the primary host and quality representative for USDA inspections, regulatory audits, customer visits, and external assessments • Ensure the facility maintains a constant state of inspection readiness. • Coordinate responses to inspection observations, audit findings, and regulatory requests • Support preparation and review of regulatory submissions and compliance documentation as required. Data Integrity and Documentatio • Ensure all quality records, laboratory records, and batch records comply with Good Documentation Practices (GDP). • Promote and enforce compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) • Establish and maintain robust data integrity practices across all quality systems. Training and Quality Culture • Ensure all personnel are appropriately trained and qualified for assigned duties. • Maintain training records and competency assessment programmes • Monitor training compliance and ensure training requirements are completed within established timelines. • Promote a proactive quality culture through coaching, mentoring, and employee engagement Reporting and Metrics • Develop, monitor, and report Quality KPIs to senior management on a routine basis. • Analyse quality trends and provide recommendations for improvement • Prepare and present quality performance reports during management review meetings. • Support strategic decision-making through effective use of quality data and metrics. Leadershi • Provide leadership, direction, and development to QA and QC personnel • Foster strong cross-functional relationships with operations, facilities, laboratories, and leadership teams. • Support organisational growth while maintaining compliance and quality standards Qualifications & Experience Required Qualification • Bachelor's degree in quality management, Biological Sciences, Entomology, Biotechnology, or a related discipline. • Minimum of 5 years' experience in a Quality Management role and inimum of 3 years' experience leading quality systems within a regulated environment • Demonstrated experience hosting and supporting regulatory inspections and audits. • Strong understanding of Quality Management Systems, Good Documentation Practices, and data integrity requirements • Experience managing investigations, CAPAs, change controls, deviations, and risk assessments. • Proven ability to analyse quality metrics and present KPIs to senior leadership. • Comply with all applicable health and safety policies, procedures, and site requirements, including laboratory safety and biosafety protocols. Preferred Qualifications • Experience working within a New World Screwworm, sterile insect technique (SIT), entomology, biological production, agricultural, veterinary, biotechnology, or animal health environment. • Experience working with USDA-regulated programmes or facilities • Knowledge of laboratory quality systems and biological production processes. • Certification in Quality Management or Quality Auditing (ASQ CQM, CQA, or equivalent) Behavioral Requirements • Commitment to, and passion for, the Flyttr mission and values. • Responsive to the needs of an international business working across different time zones, adapting working patterns in-line with business requirements. • Positive, humble, co-operative and professional always. • Works with urgency and solves things promptly. • Resilient and persistent in an innovative and constantly changing environment. • Proactive, resourceful, and comfortable building processes from scratch. • Values collaboration and works effectively with global colleagues. At Flyttr, you will be at the forefront of critical global biosecurity efforts, working alongside a dynamic team of leaders, technologists, scientists, engineers, commercial teams, regulatory experts and operational drivers on the front lines. You will have the opportunity to directly shape the policy landscape for pioneering technologies and build the critical relationships necessary to protect global agriculture and public health.