Dawn Houlihan
Vice President of Quality at Ensoma
- Role
- Vice President of Quality at Ensoma
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Dawn Houlihan
I have over 21 years Quality Assurance and Quality Control experience within the Bio-pharmaceutical, Diagnostic and Medical Device industries. My career to date has been strongly focused on quality and operations, and I have gained increasing responsibility in a variety of technical, leadership and project management roles. I have extensive auditing experience including leading of external (supplier) and internal audits, as well as co-ordination of/participation in Health Authority inspections, including FDA, KFDA, and ANVISASpecialties: Quality Assurance, Batch record and documentation review, Quality Systems (including DocSpace and TrackWise, as well as the use of SAP), Aseptic Manufacturing, Cell Culture and Purification Operations, Auditing, Technology Transfer and New Product Introduction
Experience
Vice President of Quality
Mar 2025 — Present
Education
University College Cork
Bachelor of Science (BSc), Physiology, General
1999 — 2002
Skills
- Regulatory Inspections
- Site Inspections
- Team Co-Ordination
- 21 Cfr Part 11
- Contamination Control
- Replenishment
- Product Release
- Laboratory Skills
- Raw Material Release
- Validation
- Purification
- Biochemistry
- Pharmaceutical Industry
- Sop
- Deviation Management
- Fda
- Technology Transfer
- Analysis
- QA
- Employee Training
- Internal Audit
- Gmp
- Tech Transfer
- Biotechnology
- Qc
- Product Introduction
- Batch Records
- Quality Assurance
- Quality System
- Mes
- Supervision
- Laboratory
- Biopharmaceuticals
- Sap
- Data Governance
- QA Lead
- External Audit
- Cell Culture
- Change Control
- Medical Devices
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