spotlight Support Bios

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Quality Assurance & Quality Validation

- Consultant with GMP working experience with a focus in Quality Assurance and Quality Validation.

- Over 13 years experience at fortune 500 and small startup biopharmaceutical companies.

• Validation Program Quality Oversight
• Gap Assessment & Continuous Improvement Identification
• Investigation Root Cause Analysis and CAPA Implementation
• Digital System & Equipment Validation
• Aseptic Equipment Validation; SIP & Autoclave Validation
• Quality System Management & Design Consultation

Clinical Compliance & Information Technology

- Consultant with clinical compliance and business process analyst including strong data analytics and compliance skills.

- Over 20 years experience supporting clinical development in the biopharmaceutical industry.

• External CMO Quality Oversight
• Validation of GxP Systems
• Document and associated metadata management in eTMF
• Program clinical data visualizations including the use of dashboards, risk identification, TLFs
• Develop custom analytics for Data Management, Safety, Clinical CRAs
• Develop and Automate ETL integration between clinical data management /
• EDC systems (e.g., Medidata Rave, Oracle Clinical), central data repositories, and visual Analytics systems (e.g., Spotfire).

Compliance & Quality Systems

- Consultant with GMP compliance and quality systems experience performing sponsor internal and external vendor audits.

- Over 25 years experience supporting fortune 500 and small startup biopharmaceutical companies.

• Vendor Audits
• Design and implement and continuously improve Quality Management Systems
• GMP Annual Training
• Batch record review/product disposition
• Digital System validation
• CMC Support

Regulatory Affairs

- Consultant with regulatory affairs with successful, proficient worldwide submission experience.

- Over 25 years experience supporting fortune 500 and small startup biopharmaceutical companies.

• Regulatory content generation & publishing
• Approval/clearance and/or maintenance of 510(k)s, INDs/IDEs/CTAs, BLA eCTD, HDEs, PMAs, and CE Mark
• Experienced and successful negotiator with regulatory authorities regarding challenging clinical trial designs and innovative approval pathways
• Developed regulatory strategies, systems, SOPs, and processes to ensure that product development, approval application, registration and commercialization plans meet US and foreign regulatory requirements

Regulatory Affairs & Quality Assurance

- Consultant with GMP working experience with a focus in Regulatory Affairs and Quality Assurance Operations.

- Over 30 years experience at fortune 500 and small startup biopharmaceutical companies.

• Batch Record Review and Product Disposition
• Biological License Application and Investigational New Drug submissions
• CAPA, supplier monitoring, internal auditing and training program Management
• Primary Quality reviewer for all validation protocols and reports
• Write Quality Agreements for suppliers and clients
• Complaint Management

Manufacturing Operations

- Consultant with GMP working experience with a focus in Manufacturing Operations.

- Over 20 years experience at fortune 500 and small startup biopharmaceutical companies.

• Batch Record Review and Product Disposition
• CMC author/reviewer for manufacturing, facilities, and utilities
• Technical Transfer
• Development of Sterility Assurance program
• Facility design, startup and commissioning
• Designed & implemented NPI strategy for Operations