Develop, implement, monitor and oversee GxP (GCP/GLP/PV/GMP/GDP) Quality Systems and Practices for all Kyverna products and operations globally. Build and lead a Quality Unit focusing quality and compliance management of Kyverna programs both in the US and internationally and maintaining the highest standards of quality in operations. Work with other executive leaders in the organization to establish and embed the Quality Standards, Policies and Culture within Kyverna and manage, investigate and communicate the companies Quality and Compliance. Providing pragmatic approaches to address risk and enable sustained compliance within all GxP areas. Support international clinical trials through quality oversight, program/study team consultation, and risk assessment. Primary point of contact for regulatory agencies and lead GxP health authority audits and inspections. Implement Inspection Readiness program and provide leadership for inspection readiness training and preparation for inspections of investigator sites, external manufacturing operations, testing operations, and logistics.

Provide quality and compliance guidance to drug and medical device development organizations including process definitions, risk management, information systems, strategic planning. Provide implementation assistance for procedures, policies, systems, and training.

As a Quality Leader for a Phase l gene editing company, built and deployed a quality function following phase-appropriate solutions, quality culture, and systems solutions. Led contract negotiations with contract service providers, resource planning, and recruiting for Phase 1 Cell and Gene Therapy Biotech. Provided GxP oversight (Manufacturing, Clinical, Pharmacovigilance, Laboratory, Distribution, and Part 11 Computer Systems) to the enterprise.

As a Quality Leader for a Phase 2-4 biotech, built and deployed a quality function following phase-appropriate solutions, quality culture, and systems solutions. Established, implemented, and enhanced/defended quality systems and processes. Contracted, recruited, and developed resources supporting Phase 2 through post-marketing operations (Manufacturing, Clinical, Pharmacovigilance, Laboratory, Distribution, and Part 11 Computer Systems)

Led commercialization of novel therapeutics through the development , implementation and maintenance of a comprehensive quality management system that is based on International Standards Organization (ISO) quality concepts, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good laboratory Practice (GLP). Support CMC activities , Regulatory Affairs activities for multiple agencies, and continuous improvement of the organization.

Independent consulting including subject matter expertise in CMC and GMP Quality Systems development and execution. Compliance with EP/USP, ICH, FDA, EMA, ISO et al., regulatory filing. Quality Engineering including Risk Management, Continued Process Verification. Six Sigma Black Belt program development and execution.

Director, Product Quality LeaderGlobal launch of product including Quality CMC sections for FDA, EMA, Health Canada, TGA, Middle East Countries, Latin America, Asia Pacific. Author and/or review sections including response to questions (RTQs) Product Quality control strategy including develop and maintain specification product risk management and strategy; Application of integrated control strategy e.g., IPC, specifications, process monitoring Analytical Comparability develop, define comparability strategy supporting process and program changes Voice of Quality at the Global Operations Team; Lead Product Quality TeamSupport Product Quality deviations, complaints and change records

Director of Quality Engineering with responsibilities for site statistics, manufacturing data trending, capacity modeling, root cause analysis.Actively recruited and developed Quality Engineering group in Amgen’s manufacturing facility in Puerto Rico. Focused on developing team’s skill in statistical analysis, modeling, and problem solving. Represented and promoted Quality Engineering to senior leadership throughout the corporation. Regularly analyzed and presented quality metrics to senior leadership.Received 2011 Excellence in Operations Award for developing and implementing a monitoring program focused on manufacturing operational excellence. Multi-million dollar savings realized from program.Led key site Quality Systems group in compliance with cGMP guidanceAccountable for the statistics capabilities of the site including statistical applications in process monitoring, Design of Experiments, and sampling strategiesProvide resources and analytics to the Product Quality Surveillance function

Delivered 20+ Lean workshops and 5 consulting engagements across Laboratories, Supplier Quality Management, Facilities, Quality Assurance and Validation. Average savings generated per 2-day workshop: $600k, with as much as $5MM from a single workshop. Applied lean methodology to Product Complaints Processing yielding zero backlogs in investigations. Developed statistically driven decision tools for quality systems and facilities metrics (run chart, control chart, management review, product reviews, dashboards)Implemented cross-site QC Workforce and Corporate Quality EHS models. Became a SME in specific solutions for Cost of Quality modeling used to identify improvement opportunities in productivity, harmonization, best practice, new site planning, and yearly budget and long range planning. Performed over 20 risk assessments including product, site, and quality system (FMEA, PHA, and FTA).

Process Excellence Engineer for sight focusing on lean and six sigma process improvements

Provide analysis of supplier capability and provide direct assistance in transformation of diverse cross section of key suppliers to improve the value chain.