OVERVIEW
FOCUS AREAS
Over 25 years of experience in the pharmaceutical, biotechnology, and medical device industries.
Deep expertise in global regulatory compliance
Quality systems
Product development
Manufacturing operations across drug, device, and combination products.
As Senior Director, Shannon works with clients to develop and delivers customized solutions to address compliance needs. She leads the Training Center of Excellence and provides expert consulting support to clients
Her experience spans the entire product lifecycle, offering strategic leadership in sterility assurance, quality, inspection readiness, validation, and regulatory submissions. She has held developed and implemented quality management systems, managed quality and compliance at small and large companies and led commercial launches and global inspections. Her collaborative approach and broad technical background make her a trusted advisor to teams navigating the complexities of development, commercialization, and global compliance.
She is a passionate educator and communicator, with experience in designing and delivering technical training programs to teams around the world. Her training services cover a wide range of critical topics, including cGMP fundamentals, aseptic processing, validation strategies, root cause analysis, and clinical trial compliance. Known for making complex regulatory requirements clear and actionable, she helps organizations build internal expertise, drive continuous improvement, and foster a culture of quality.
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EDUCATION:
- ISPE, San Diego Chapter Vice President
- Parenteral Drug Association
- Women in Bio
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Experience:
- Azzur Group, Senior Director 11-20 – Present
- Heron Therapeutics, Inc., Director, Manufacturing and Development 09-15 – 08-20
- V2 Bio-Consulting, Inc., Director, Quality Engineering 06-12 – 09-15
- Novartis, Vaccines & Diagnostics Manager, Validation 01-11 – 06-12
- V2 Bio-Consulting, Inc. Manager, Quality 06-08 – 12-11
- Alza Corporation Manager, Validation 01-06 – 06-08
Other Experience:
- AMEC Engineering Senior Manager
- Accumetrics, Inc. Formulation Scientist
- Advanced Tissue Sciences, Inc. Production Associate
- Hybritech, Inc. Laboratory Associate
Areas of Expertise:
- Training
- Aseptic Processing
- Combination Products
- Product Development
- Chemistry Manufacturing and Control (CMC)
- Product Lifecycle Management
- Project Management
- Quality Assurance and Systems
- Manufacturing Operations
- Design Control
- Package and Label Development
- Risk Management
Ready for Regulatory Clarity?
Contact us today and learn how ELIQUENT guides companies from risk to readiness.