Co-developer and Practice Lead for Quality Pulse® quality culture diagnostic, working with Life Sciences companies to assess their Quality Culture and develop outcome-based improvement plans.The Quality Pulse® quality culture diagnostic is a scientific, research-based quality culture assessment model designed specifically for FDA-regulated and life sciences companies. The methodology was developed and adapted from well-established research, including:- Organizational culture principles of Edgar H. Schein (MIT/Sloan);- System dynamics principles of Peter Senge (MIT/Sloan);- Research articles on corporate culture, quality culture, and organizational behavior, many in the life science context from 2000-present; and- Decades of direct experience in quality operations across a variety of life science (pharma/device/biotech) organizations (100-100,000 employees).Developed specifically to help organizations of all sizes understand the drivers of their culture of quality, the methodology and outcome reporting provides actionable intelligence that helps company leadership direct and implement improvement programs that will result in better quality outcomes and improved organizational excellence.For more information, see www.compliancearchitects.com/quality-pulse

I work with organizations as they embark on strategic change or face challenges/duress. I use a Compliance ReimaginedTM methodology to leverage synergies between Five Domains--- Strategy, Governance, Compliance, Transformation, and Learning, to achieve desired outcomes.TECHNICAL EXPERTISE: System Analysis & Design Thinking, Learning Strategy, Quality Management, GMP/GxP and Pharma Compliance, Collaborative Negotiation, Identifying Unconscious Bias, Risk Management, QA/QC & Supply Operations, Pharma Drug Development Life Cycle, Process Improvement and Reengineering; Policy Systems, Enterprise Governance/Risk/Compliance (GRC); Document/Content Management, Change Management, Mentoring/Coaching & Team Building.

In a project sponsored by CEO/CIO/CHRO and CCO, led an enterprise-wide transformation of learning.• Comprehensive assessment of current state learning technology and processes.• Developed future state vision, strategy, governance and operating model• Addition of “Curiosity and Continuous Learning” to Corporate Values• Implemented Workday Learning as a common technical platform, with transition plan.• Implemented a Managed Service Delivery model for new learning content• Partnered with Workday on multiple Design Teams and Advisory Council to ensure life-science compliance requirements are met.

Reporting to the Chief Compliance Officer, responsible to identify and develop enterprise quality and compliance initiatives, strategies, and provides leadership and governance to comprehensive governance and compliance risk management systems. Major accomplishments: • Developed an enterprise GRC risk model using Bowtie methodology to consolidate compliance risks across multiple regulatory/compliance domains at request of the Chief Compliance Officer.• Aligned and led governance of 12 cross-functional GxP QMS & compliance processes, integrating metrics and reporting into a single enterprise compliance/risk/governance technology system. • Cross-functional technology governance processes externally recognized as “best practice” in field.

Responsible for developing and implementing a global quality system for all Celgene sites worldwide, coordinating and monitoring key quality metrics on a global basis, and a member of the Global Quality and Compliance Leadership Team. Developed and implemented a global, scalable, integrated quality management system, including a single technology platform, for both commercial and clinical supply chains, including Complaints, Change Control, Document Management, Investigations, CAPA, Regulatory Filings, Compliance Auditing and Global GMP Policy.

Responsible for leading and managing PSQ staff located in both the US and Werthenstein AG (WAG), Switzerland, with the goal of optimizing Quality Strategies to ensure that effective and efficient global processes are in place which are compliant with local Swiss law, EU GMPs and the Clinical Trials directive, and FDA GMP requirements. Led strategic reengineering of 7 compliance/quality management processes and systems for the Clinical Supply chain organization, while maintaining compliance to Department of Justice/FDA Consent Decree commitments.

Responsible for the development, implementation, training, and assessment of global pharmaceutical manufacturing quality policy and standards to meet US FDA and International Good Manufacturing Practice (GMP) regulatory requirements.

Responsible for the development and execution of global quality system improvement projects. Major accomplishments/projects:Global implementation, training, and compliance assessment of GMP standards across 19 strategic sites in the US, Puerto Rico and Europe. Developed, validated and implemented a glboal, web based assessment tool, with real time executive dashboards to report compliance status and CAPA reporting. Led Compliance Action team to verify compliance of all NDA parameters across the manufacturing supply chain. Developed a global, multi-site/multi-product web based assessment tool to map filed process parameters into database structures to effectively manage complex/multiple permutation supply chains.

Site quality leader and member of site leadership team. Responsible for all Quality Assurance functions, and QC/GMP labs for API release testing and a 24x7 in-process laboratory, supporting of one of world’s largest API sites. API products included corticosteroids, antibiotics, cephalosporins, controlled substances, sterile APIs, micronized products, prostaglandins, and traditional synthesis APIs, utilizing ca. 600 different reactions to produce 180 different API SKUs. Prior roles with The Upjohn Company and Pharmacia included Senior Research Chemist and various QA roles of increasing responsibility, before assume the Site Quality Head role in 1999.