Alison Higgins Email & Phone Number
Director Quality (Technical Quality Operations)
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Alison Higgins Location
- Somerville, MA, US
Alison Higgins Work
- Director Quality (Technical Quality Operations) @ Halozyme (formally Elektrofi) (March 2024 - Present)
- Director Quality Systems @ Albireo Pharma, Inc. (March 2022 - December 2023)
- Head Of Quality Assurance @ (March 2020 - March 2022)
- Senior Quality Assurance Consultant @ Independent (May 2014 - March 2020)
- Quality Assurance Manager @ (February 2013 - April 2014)
- Quality Compliance Engineer @ (April 2012 - February 2013)
- Quality Engineer @ (September 2011 - April 2012)
- Quality Compliance Specialist @ (July 2009 - September 2011)
- Senior Quality Specialist @ (September 2002 - August 2003)
- Quality Supervisor @ (September 1999 - September 2002)
- Validation Engineer @ KMI/PAREXEL (July 1996 - September 1999)
Alison Higgins Education
- Trinity College Dublin
Engineering
1990-1994
Alison Higgins Skills
- 21 CFR Part 11
- Batch Records
- Biotechnology
- Business Relationship Management
- CAPA
- CMOS
- Change Control
- Clinical Practices
- Combination Products
- Computer System Validation
- Defining Requirements
- Deviation Management
- Deviations
- EMA
- Emerging Trends
- Equipment Qualification
- External Audit
- GMP
- Internal Audit
- Issue Management
- New Drug Application (NDA)
- Non-clinical
- Part 820
- Performance Improvement
- Pharmaceutical Industry
- Pharmaceutical Manufacturing
- Presentations
- Problem Solving
- Process Auditing
- Quality Assurance
- Quality Auditing
- Quality Investigations
- Quality Operations
- Quality Processes
- Readiness
- Readiness Assessments
- Regulatory Audits
- SOP
- Strategic Thinking
- Supplier Evaluation
- Supplier Management
- Team Management
- Training Management
- U.S. Food and Drug Administration (FDA)
- Validation
- Vendor Management
- Vendor Qualification
- Web Conferencing
- Work Alone
- cGMP manufacturing
Alison Higgins Summary
- Alison Higgins, based in Somerville, MA, US, is currently a Director Quality (Technical Quality Operations) at Halozyme (formally Elektrofi). Alison Higgins brings experience from previous roles at Albireo Pharma, Inc., LiquiGlide, Independent and AMAG Pharmaceuticals. Alison Higgins holds a 1990 - 1994 Engineering @ Trinity College Dublin. With a robust skill set that includes 21 CFR Part 11, Batch Records, Biotechnology, Business Relationship Management, CAPA and more. Alison Higgins has 1 emails and 3 mobile phone numbers on RocketReach.
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