Paul Osullivan

About Paul Osullivan

Wide range of working knowledge across all validation disciplines including process validation, shipping and cold chain storage, computer systems, method validation, facility utility systems and equipment, process equipment, sterilization, cleaning validation, and periodic requalification programs. Leading and managing teams in achieving high performance and exceptional job satisfaction.

Experience

1. Director, Quality Assurance

   Bluebird Bio

   Oct 2016 — Present · Cambridge, MA, US

   Establish and oversee a team that delivers on bluebird bio’s strategic and operational quality goals supporting manufacturing and release of bluebird bio products.• Develop and execute successful product Tech Transfer Plans in compliance with bluebird bio Validation Program requirements.• During batch production, ensure unexpected events are handled compliantly and in a timely manner and are escalated as required in bluebird bio procedures.• Ensure successful CMO pre-approval inspection (PAI) preparation enabling successful PAI execution at CMOs.• Ensure an appropriate and consistent approach in quality expectations of CMOs, including establishment of Quality Agreement, external quality oversight and escalation related to bluebird bio’s review and approval of technical protocols and reports, deviations, CAPA, Change Control, Out of Specifications (OOS) and lab investigations. • Manage adherence to scheduled timelines for bluebird bio drug project and/or product release/disposition.• Prepare key performance indicator data via review, analysis and identification of trends of quality system records at CMOs and provide periodic updates to Quality Leadership• Review and approve internal and external documentation, ensuring compliance with applicable US and EU cGMP regulations and industry standards and guidelines.• Identify issues and effectively and proactively resolve them in a diplomatic, professional, and constructive manner.• Lead a team of dedicated professionals via directing, mentoring, coaching and development toward professional growth, enhanced performance and career satisfaction.

Education

• University of Massachusetts Lowell

  Mathematics, Injection Molding

  1990 — 1997

Skills

• Project Management
• Iso 13485
• Gmp
• Cleaning Validation
• Cgmp Manufacturing
• Quality by Design
• Aseptic Technique
• Sterilization
• Regulatory Affairs
• Purification
• Sop
• Deviation Management
• Fda
• 21 Cfr
• Gxp
• Equipment Qualification
• Aseptic Processing
• Biopharmaceuticals
• 21 Cfr Part 11
• Quality System
• V&V
• Technology Transfer
• Computer System Validation
• Medical Devices
• Capa
• Regulatory Submissions
• Manufacturing
• Design Control
• Cgmp Practices
• Chromatography
• Fda Gmp
• Risk Management
• Lims
• Biotechnology
• Gamp
• Glp
• Validation
• Change Control
• Deviations
• Regulatory Requirements