Senior Quality, Regulatory and Patient Safety Executive and Authority, who orchestrates R&D, technology transfer, production/manufacturing, medical and clinical affairs and product surveillance to efficiently bring safe and competitive products to market. Understands that protecting the patient is the best way to protect your bottom line. A natural leader who will hire, coach, and mentor an exceptional team to enhance quality assurance, regulatory and patient safety programs. Broad experience within the pharmaceutical, biotech, medical device industries. Speaks FDA/global regulatory language fluently, navigating the regulatory maze with uncanny savvy. Respects the opinion of all stakeholders, examining every viewpoint to ensure problems are properly defined and solutions work for all involved. Selected achievements include:
Overcoming Compliance Challenges: developed Quality and Patient Safety processes and systems to exceed the FDA Deputy Director Compliance requirements, in the wake of a consent decree, allowing Abbott to continue shipping products to customers.
Affecting Regulatory Change: Persuaded federal and state legislators to provide favorable regulatory rulings and healthcare reimbursement to physicians for novel diagnostic products; developing Health Economic solutions to enhanced patient care.
Leadership: Over the course of career, brought into multiple global manufacturing sites with quality/manufacturing issues, turning around backorder or quality issues, developing sustainable solution within 30 day; focusing on regulatory compliance and patient safety.
Expertise that Drives Enhanced Productivity and Growth
- Global Quality System
- Risk Management Life-cycle planning and execution
- Drug-Device Safety Reporting
- Regulatory Inspection Readiness
- Product / Patient Risk Management
- Continuous Improvements
- Supplier Management/Auditing
- FDA 483 remediation/Consent Decree strategy
- Organizational Agility
- Regulatory / Business Compliance
- Technology/Design Transfer
- Global Regulatory Submissions
- Due Diligence/Mergers and Acquisitions
- Business / Product Development
- Coaching and Mentoring
- Internal Auditing program
- Total Lifecycle Project Management
- Product, Process and System Validation
- Regulatory Agency Inspections
- Staff augmentation
Solution-focused consulting company; translating the global needs of our customers into complaint business solutions: Working as an Interim Executive or with Executive Management teams to provide process-based resolutions for sustainable growth and compliance.
Provided strategic leadership and managerial oversight for consulting and staff development services for delivery of regulatory, quality assurance, and Safety Operations organizations in the pharmaceutical, medical device, combination products, and biotechnology sectors, for companies including: Serepta, Canon Life Sciences, MonoSol RX, Medtronic and Genentech.
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- Coaching and Staffing Development: For over 400 Quality and Regulatory professionals through interactive training, and mentoring oversight to over a dozen Vice President level professionals to enhance their quality, management and process effectiveness skills.
- Quality System and Regulatory Compliance: Established Quality Systems; incorporating traditional Quality requirements, global regulatory requirements and patient safety for Pharma/Biotech and Medical Device industries. Aligning product development, quality and regulatory deliverables to reduce cycle-time, defining roles and responsibilities for clear decision making and team alignment.
- Product Development and Product Transfer: Developed processes based on Company needs, allowing the seamless transfer of information and requirements between R&D and Manufacturing, while building robust production, post-market support and supply quality programs. Successful development of Quality System, Design Development and manufacturing/testing requirements for Canon Life Sciences initial product offerings. Established R&D transfer and testing requirements to enhance production yields and First-pass Acceptance for Serepta oligonucleotide formulation.
- Project Management: Established cross-functional and cross-culture process tools leading to success projects for new product development, manufacturing (technical transfer, validations), compliance (business and regulatory), cost-enhancements, acquisition integration, organizational development and regulatory approvals. Strategy lead to cycle time improvements to regulatory submissions; enhancing time to market.
- Validation: Establishing requirements for product, process, computer systems and manufacturing: Using Risk-based decision criteria in establishing critical requirements and effective/efficient test plans.
- Established risk based Supplier Quality and audit programs (Internal and Vendor) providing continuous improvements, sustaining Quality Systems and global compliance.
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