• Developed enterprise Supplier Quality program and global team overseeing supplier lifecycle management within Medical Device and Pharmaceutical industry encompassing clinical, aseptic, implantable, and OTC product portfolio.• Led initiatives to enhance supplier quality, reduce time to market, and drive continuous innovation while minimizing supplier risk.• Developed and executed strategies to improve raw material inspection practices, ensuring continuous manufacturing and business continuity.

Key decision maker within Novartis’s Sandoz division assessing US product quality and compliance to facilitate FDA reporting including notification and primary liaison with FDA district coordinators.Develop and execute Product Recall activities as required for over 200 Aseptic, Oral Solids, and Biosimilar drug product families manufactured at both foreign and domestic CMOs, sister sites, and regional facilities.Primary liaison with FDA Recall Coordinators to assure compliance throughout product recall lifecycle including internal review, initiation, monitoring, and closure.Direct divisional colleagues at both foreign and domestic Aseptic, Oral Solids, and Biosimilar firms to assure compliance to FDA regulations within Product Launch, Root-Cause Investigation, and CAPA effectiveness.Established internal supplier (i.e. sister sites) management program for US market through negotiation of comprehensive Quality Agreements and development of Investigation/Deviation workflows, CAPA management, and dashboard metrics. Participate within inspection readiness teams and provide on-site support during domestic and foreign FDA inspections.Six Sigma Black Belt project manager driving reduction in quality rejects and increasing efficiency within product manufacturing towards Right First Time excellence. Established Quality and Regulatory Compliance requirements for Private Label and Repackaging business strategies.

Developed and governed Supplier Quality compliance through successful warning letter remediation across multiple facilities within ‘Americas’ region through a risk-based harmonized program. Responsible to ensure compliant supplier quality and audit compliance monitoring, Quality Agreement execution, deviation/investigation management, including integration within Global Novartis network to cascade practices.Execute continuous improvement within Supplier Quality activities associated with contract services, API, excipient, packaging materials, warehouse/distribution, testing laboratories, and acquisitions.

Authored and implemented centralized Supplier Quality Assurance program across 25+ pharmaceutical and consumer healthcare production sites with diverse delivery technologies including sterile, inhalation, combination device systems, encapsulation, biologics, and oral solids. Managed within multi-level direct reporting structure to achieve efficiency and operational excellence through cross functional partnership and program management initiatives delivering improved compliance results within both Clinical and Commercial programs year over year with focus on audit program adherence and supplier performance.Deployed risk management program across vendor selection, qualification, and monitoring processes with improvement through key measurements such as Supplier OTD and reject rate to facilitate compliant supply base including support of secure LCC sourcing initiatives.Spearheaded cross functional crisis management team to mitigate emerging threats to supply chain security and product integrity through the elements of risk management and SRM methodologies.Authored Corporate Policies and SOPs within Global QMS system to standardize framework on supplier assurance leading to centralization of related activities and favorable outcomes from 30+ competent authority inspections.Established and monitored control of operational budget to effectively execute Global Supplier Audit program with over 300+ annual supplier site audits including integration of strategic growth initiatives and acquisitions.

Certified Quality/Regulatory Compliance auditor within pharmaceutical firm managing internal and external compliance for a combinational pharmaceutical drug and medical device product to 21CFR Parts 11, 210, 211, and 820 including EU-MDD, ICH, and ISO 9001/13485 regulations. Supplier Quality lead focusing on Quality Agreements and product discrepancy resolution with critical vendors and contract manufacturers focused on design, validation, and commercialization activities of device and drug product components and finished assemblies. Responsible for designing, executing, and maintaining risk-based, phase appropriate compliance initiatives for new and existing vendors for all key device component and packaging vendors.

Managed multiple class III Endo-mechanical surgical product lines and product safety through global post market surveillance including final Quality oversight of root-cause analysis into reported product issues. Evaluated high volume global product incident reports and facilitated adverse event reporting to FDA, Asia, and EU (MHRA, EMEA, BfARM) Authorities. Developed and executed proactive visits with senior clinical staff, lead surgeons, and executive hospital administration at key accounts to discuss product quality issues, user conflict resolution, and provide internal feedback to support continuous improvement. Identified and reported emerging events through product performance trending including complaints/defects to initiate immediate corrections and long term preventive actions.Effectively collaborated with cross-functional teams such as Engineering, R&D, Marketing, Business Development, Sales, Education, Legal, and Manufacturing to develop and implement corrective actions and new product initiatives to address product issues and process improvement.

Designed and facilitated: R&D testing, IQ/OQ Equipment Qualification, and Analytical Development on proprietary Genomic DNA sequencing technology. Optimized biomagnetic and non-biomagnetic bead separation technology for controlled enzymatic activity and DNA/Primer strand attachment.Implemented transition of Full Sequencing Platform from R&D to commercial service model by application of high-throughput workflow strategy and cross-functional training. Cited author in Nature Science Journal on “Genome Sequencing in Microfabricated High-density Picolitre Reactors” - Jan. 2006

Responsible for creating, training, and monitoring effectiveness of work instructions and corporate procedures for high-throughput gene expression technologies including: Tissue to cDNA preparation, Primer Adaptor Chemistry, Capillary Electrophoresis, DNA Band Isolation/Identification, Real Time Quantitative PCR replication, and Data Analysis.Developed and maintained GLP/GMP training program for production staff. Conducted departmental audits for SOP adherence and compliance according to applicable GLP and GMP standards.Monitored, prepared, and reported QA/QC trending metrics for senior management.