Rick Houle

Experience

1. Lead, Business Development & Contract Manufacturing Business Quality

   Takeda

   Apr 2022 — Present · Boston, MA, US

   Develop, implement, and lead Quality strategy and supporting processes for in-licensing, out-licensing, collaborative partnerships, mergers, and acquisitions in support of Business Development (BD) projects and for management of external partnerships with Contract Manufacturing Business (CMB) customers.• Provide Quality leadership to internalization & externalization BD due diligence activities. Lead Quality GxP subject matter experts as part of the CMC team through engagement with other global functions (e.g, Legal, Marketing, Regulatory Affairs, etc.) to review and evaluate the asset/company to ensure proper fit within the company’s portfolio and strategy, to identify key risks, and develop mitigation strategies.• Provide strategic Quality oversight of CMB partnerships and support CMB engagement between external CMB customers and internal manufacturing sites (e.g, Quality Agreement ownership, escalation point of contact, lead Quality-to-Quality meetings, Quality lead for business review governance meetings, support timely completion of CMB related Quality Events, change controls and appropriate regulatory filings, etc.).

Education

• Northeastern University

  M.S., Regulatory Affairs for Drugs, Biologics and Medical Devices

• University of Vermont

  B.S., Biological Sciences

Skills

• Quality Assurance
• Biotechnology
• Internal Audit
• Quality Control
• Product Security
• Gmp
• Adult Education
• Microbiology
• Regulatory Affairs
• Global Regulatory Compliance
• Quality Management
• Biopharmaceuticals
• Site Inspections
• Quality System
• Document Management
• Stock Recovery
• External Audit
• Supplier Management
• Product Complaints
• Iso 13485