Vice President of Quality Assurance & Regulatory Affairs

• 20+ Years in Medical Device/Combo Device Manufacturing
• Currently responsible for 7 Domestic and International Geographies, approximately 15 facilities across 3 Business Units
• 250+ Quality Professionals reporting up through my Quality Organization
• Corporate Life Sciences & Sterilization Team Including Microlab and previously an EtO Sterilization facility
• 15 FDA Inspections - CDRH, CDER, CBER
• OEM & CMO Industries
  • Viant Medical (14 Years, CMO)
  • Electrochemical Oxygen Concepts (3 Years, OEM)
  • Smith Nephew (6 years, OEM)

Bryan’s Resume

[email protected]

My Approach

Systems & Workflows

I believe strongly that consistent performance and improvement is derived from building and implementing documented systems and workflows that drive repeatable behaviors within the organization. Here are a few of the impactful systems I have developed.

Investigation Tools & Templates

• Developed a set of templates for performing root cause investigations that ensures effective communication across all tiers of the organization (Shop-floor to ELT) and use of all of the requisite tools to drive robust outcomes.
• Data shows that long term implementation of high standards in root cause investigation drives Tier 1 metrics to best-in-class performance. (Data below is the cumulative data for all sites within scope of responsibility)
  • 78% reduction in Complaints
  • 66% reduction in Nonconformance

4 Data-Signals of QMS Maturity

• Developed a Quality System Maturity Model based on 4 data signals (Complaints, Nonconformance, CAPA and Internal Audits)
  • Raw data signals place a site’s Quality System into one of 4 maturity levels.
  • Each level has a tactical list of initiatives to drive maturity to the next level.

VECTOR Checks (Verification of Environment, Compliance, Traceability, Operations, Records)

• Quality is built into the product on the shop floor.
• Developed a shop-floor Quality program called VECTOR Checks that organizes the activities for Quality professionals when walking the production floor to drive compliance.

Quality Leaders Development

• Comprehensive Organization and Management of Quality Leadership Tasks
• Prioritization and Decision Making
• Delegation and Accountability
• Conflict Management & Negotiation
• Headcount Modeling for Right-Sized Quality Organizations