Having advanced to a director role through demonstrated leadership and outstanding performance in QA and QC, I was personally appointed by the Acting CEO to oversee QA, QC, Manufacturing, and Supply Chain operations. In this capacity, I hold full responsibility for our Quality Management System (QMS), conducting regular quality process reviews, internal audits, and managing change control processes. Moreover, I actively support new product development within QC laboratories, ensuring adherence to cGMP regulations and successful product launches.Among my key achievements, I:- Secured ISO 9001:2015 recertification as Associate Director, Quality, achieving perfect scores in annual audits with 0 observations and 0 non-conformances.- Led establishment of company's QMS, QC and QA KPIs, and quality management review processes. Served as Chairman of the Change Control Board, guiding effective implementation of process improvements across startup operations.- Developed data-driven manufacturing SOPs to support increased in-house production, collaborating with Manufacturing. Implemented comprehensive GLP and GMP training emphasizing CFR guidelines and ISO compliance, ensuring alignment across product lifecycle and priorities communicated effectively to lab technicians.- Utilized deep expertise in ISO 13485:2016 to support ongoing certification efforts at TwinStrand.

I advanced from a QA/QC Head role to an Associate Director position, spearheading the development and refinement of QA/QC processes while managing critical stability investigations. Moreover, I provided strategic oversight for all QC activities, assessing new materials to establish optimal test methods, metrics, and validation/qualification standards. My leadership included owning the execution of internal quality audits and facilitating seamless external quality inspections, ensuring compliance and operational excellence.Among my key achievements, I:- Achieved ISO 9001:2015 certification flawlessly with 0 citations, observations, or improvement recommendations, navigating through organizational restructuring and limited resources.- Addressed chronic customer complaints on purchased reagents by identifying and resolving vendor-sourced material issues, successfully transitioning manufacturing in-house, resulting in improved product performance and significant cost savings with no further complaints.- Achieved a 30% reduction in production costs for a molecular diagnostic product through strategic redesign of packaging. Collaborated closely with supply chain, manufacturing, and quality teams, utilizing data analytics and effective communication to secure leadership buy-in for implementing cost-efficient design changes.

I have independently developed and implemented over 600 documents within our company's quality management system, focusing on internal audits and traceability. Through strategic leadership, I drove operational enhancements that were pivotal in achieving CLIA and ISO 9001:2015 certifications. By fostering cross-departmental alignment, I facilitated discussions that integrated QA/QC functions seamlessly into every operational facet, ensuring sustained quality and regulatory adherence.Among my key achievements, I:- Managed and oversaw all QC and QA processes for a startup, developing, implementing, and ensuring adherence to high-quality standards. Ensured compliance with ISO, cGMP, and client SOPs.- Spearheaded ISO 9001:2015 certification preparation, building teams and implementing enhanced quality management systems meeting rigorous standards and compliance requirements.- Hired, mentored, and managed performance of QA/QC operations team. Provided guidance to Acting Director of Supply Chain and key leaders, fostering team engagement and maximizing performance.- Implemented equipment calibration processes and procedures, setting validation criteria and best practices to maintain equipment functionality, accuracy, and result integrity.

I spearheaded Quality Control initiatives as the cornerstone of a pioneering start-up in immune-driven medicine solutions. With a focus on meticulous process implementation and continuous enhancement, I ensured our QC practices consistently met stringent standards, crucially supporting laboratory operations. My role extended to providing expert QC guidance during audits and swiftly conducting root cause analyses for non-conformance issues, driving proactive problem-solving and operational excellence.Among my key achievements, I:- Was recognized for exceptional team leadership, fostering strong relationships across organizational levels.- Led a successful high-performing team-building course, showcasing expertise in diverse team management. Presented to directors and senior managers, earning their trust with a comprehensive delivery.