Experienced Board Member, CEO and senior executive with proven ability to build, develop and grow international businesses. A highly strategic and results focused visionary leader for building and developing early stage, turn-around, and established companies. Repeated success in leading early stage and established companies to the next level of growth and expansion. Extensive and diverse experience that provides valuable perspectives and insights to Boards and corporate management across the company in setting vision, focus, goals, and strategies that produce the best possible results. Balancing drive and passion for growth with fiscal responsibility while generating the highest possible ROI.

A full-service international consulting and product management firm that provides CMC development, manufacturing, regulatory affairs, launch, and operational support to pharmaceutical and biotech companies.​

Cintas Cleanrooms use a highly specialized laundering process with strict standard operating procedures and stringent requirements that meet and maintain ISO 9001 certification. We provide gowning services and cleanroom supplies to ensure that your facility is functioning at peak performance.

Global experience in drug and device clinical development/safety monitoring, business development, regulatory interactions and public-private partnerships;board-certified neurologist/epileptologist;patient advocate; clinical and industry consultant.

Quality Assurance and Compliance; GCP/GLP/GCLP/GMP/CSV/Part 11; Training, auditing, SOPs; drugs, devices, biologics, dietary supplements

1. Provide three distinct professional services: Enable – Establish a culture of excellence to build in quality and avoid the costs of poor quality; Solve – Provide problem solving expertise and applying over 30 years of practical experiences to solve the organizations most critical issues; and Enable – Equip an organization’s employees through training and development.
2. Fractional or Permanent leadership role in Quality, Continuous Improvement, or Transformation leadership.

Competencies:
LEAN, Six SIgma, Continuous Improvement, Process Design, Product Development, Risk-based Quality Management, Customer Quality, QA, QC, Regulated Industries, Global Standards, Medical Devices, GMP, Life Sciences, Operations, Manufacturing, Product Services,

In the dynamic landscape of today's business world, Purple Raven stands as a stalwart partner, dedicated to
ensuring the heartbeat of your business never falters. We recognize the relentless nature of cyber threats,
regulatory pressures, and customer demands, and we are here to fortify your organization against these
challenges. Our commitment is not just to security but to the seamless integration of robust cybersecurity
measures into your business strategy.

As a former FDA Investigator with 30-years of industry expertise, I prepare medical device and IVD companies to be ready for their next FDA inspection and Notified Body audit in the areas of compliance and quality.

- 30 years of experience in the creation, maintenance, remediation, and auditing of quality system and technical documentation for sterile and non-sterile medical device and in vitro diagnostics (IVD) companies from startup stage to fully commercial to ensure compliance with domestic and international quality and regulatory requirements.

- Support my clients by providing expertise in building, training, leading, and motivating high-functioning quality and regulatory compliance teams ensuring lasting knowledge transfer and inspection readiness.

- Talented internal and supplier auditor having practical experience with FDA inspection techniques, Quality System Regulation (QSR and QMSR), and on-site inspection procedures.

- Proficient in European and Global quality system standards such as ISO 13485, ISO 14971, ISO 9001, and the EU Medical Device Regulations (MD/AIMD, IVD) and associated Technical Documentation.

- Work extensively with contract design and manufacturing organizations (CDMO) to ensure that product is designed and manufactured in compliance with client, US, and international quality system requirements.

- FDA-483, Warning Letter, and Consent Decree responses and overall compliance.

Areas of Expertise:
FDA Regulations / QSR / QMSR
ISO 13485 Quality Management Systems
FDA Inspection Procedures
Quality System Inspection Technique (QSIT)
Quality Assurance
Quality Systems
Quality Control
Regulatory Compliance
Change Control
Culture Change
FDA Readiness and Remediation
Recall / Field Action
Complaint Handling
Internal, Supplier, Third Party Audits
Inspection and Testing
Process Control
Control of Nonconforming Product
Corrective Action (CA)
Preventive Action (PA)
Qualification and Validation
Design Control
Management Review
Project Management
Clinical Trials
Sterilization
Product Stability
Calibration
Preventative Maintenance
ISO 14971 Risk Management
ISO 9001 Quality Management Systems
ISO 19011 Audit Management
AIMD / MD / IVD / Biotechnology
Start-up companies
Class I, II, III Medical Devices
Expert Witness

Transforming vision into reality for clients related to my experience building collaborations and bringing together the right people at the right time to make great things happen. Successful experience in consulting, investing alongside angel and VC firms, drug development, biotech, pharma, CRO management, R&D, project management, informatics, sales and marketing, strategy, leadership, working with and mentoring entrepreneurs and university spinouts, quality/regulatory, designing and building state of the art high tech facilities, building world-class academic programs, grant funding, exit strategy and acquisition planning, economic development, partnering with industry on workforce needs and talent pipelines. Experience representing state government on matters related to science, technology & innovation. Extensive board experience.

Expertise:
consulting
investing
drug development
CRO management
R&D and innovation
project management
sales
marketing
business development
leadership
strategy
working with entrepreneurs
mentoring
quality/regulatory
design and building high-tech facilities
creating world-class academic programs
grants
exit strategy/acquisition planning
economic development
partnerships/collaborations/alliances
academia
workforce training and talent pipeline
government experience
board experience

Non-Executive Board Member. Medical Device and Clinical Trials CEO for multiple companies. Strengths are Strategy, Talent ID, Team Building and Growing businesses at accelerated rates.