Tarrah Bushee, MSJ

Spearheaded quality improvements and regulatory compliance at Diasorin, resulting in enhanced product quality and customer satisfaction. • Implemented strategies to align quality approach for molecular diagnostic products across the corporation. • Directed activities of employees to maintain daily operations and talent through recruiting and development opportunities. • Acted as IVDR Person Responsible for Regulatory Compliance (PRRC) to ensure adherence to regulations and standards.

Responsible for global quality operations for the Bioanalyzer and Genomics Divisions. These two divisions consist of seven manufacturing sites which are located throughout the US, UK, and APAC. These organizations provide a diverse portfolio of research and regulated instrument platforms as well as assay content to our valued customers.

Responsible for ensuring Quality Compliance with ISO 13485/9001, ICH7, 21 CFR Part 820, IVDR, USDA, DEA, and other regulatory requirements throughout campus of five manufacturing and research and development sites.

Overall accountability for the harmonization and compliance profile of eleven Laboratory Products Equipment (LPE) facilities. Collaborated with locations to ensure the appropriate compliance metrics and processes were in place to maintain (and scale) compliance with ISO 13485/9001, FDA, MDR/IVDR, and other global regulations.

Partner with a staff of 55 (6 direct and 49 indirect at various levels) which comprise the Quality Control, Quality Engineering, Internal Audit, Quality Compliance, and Regulatory Affairs departments. Provide site strategic and tactical direction for Quality. Most responsible site person for Quality/Regulatory for the Business Unit.

Developed and led a cross-functional global team comprised of clinical quality professionals, to implement risk management strategies to improve compliance for clinical trials located throughout the world.

Developed and implemented risk mitigation strategies and processes, including the development of a risk-based internal audit program, to ensure the quality system was complying with applicable global regulations and standards (FDA, CFDA, MDSAP, ISO, etc.). Defended the Memphis campus of sites against the FDA and other global regulatory authorities.

Responsible for maintaining quality compliance for the Orthopaedic division of Smith and Nephew. Lead and developed a successful team of Quality Professionals to proactively identify and mitigate risks through auditing (internally and externally) and knowledge of external regulatory trends. Executed audit readiness activities to prepare for inspections by regulatory agencies (including Technical File audits, FDA inspections, CFDA inspections, and various other ROW agencies).

Managed the Internal Audit program for the S&N Memphis, TN facility. Lead team of consultants to develop a risk-based audit program resulting in a 33% decrease in regulatory agency findings. Reinvigorated the culture to proactively identify issues by the implementation of a CAPA program that was efficient and effective. Represented the Internal Audit program for all regulatory inspections.

Maintained compliance with CAPA, Internal Audit, Management Review, and other quality programs. Lead the successful adoption of Global Audit procedures. Managed a team of professionals including Document Control, MDM, and Training Specialists.

Maintenance of the QMS and operating procedures to ensure alignment with current GMP/QSR, ISO 13485, and MDD/IVD directive requirements

Implemented and Administered the Corrective Action Database Implemented ERP system in order to efficiently process Document Control, Engineering Change Orders, Customer Contract Reviews and various other control functions Manage and administer the ECR and DCO processes while ensuring compliance to the applicable standards Project Manager in the implementation of ISO 13485:2003 and ISO 9001:2008 Training of employees to ISO requirements Lead Internal Auditor

Medical Device and Pharmaceutical Law