Siobhan Ashmore
Quality & Compliance Practice
BACKGROUND
FOCUS AREAS
Siobhan Ashmore brings over 30 years of global experience across the life sciences industry, supporting organizations ranging from startups to multinational pharmaceutical, biotechnology, medical device, dietary supplement, and compounding pharmacies
- Regulatory Submissions: NPI’s BLA’s, NDA, ANDA, PAI, CMC
- QA system implementation/remediation
- Digital systems, Global software systems, Manufacturing, Operational excellence
- Global Auditor
- Remediation: 483, warning letter, consent decree
- Data Integrity, CSV, Digital twin technology
Training
As Partner of ELIQUENT Life Sciences, Siobhan Ashmore advises and supports life science companies navigate complex problems in adherence to global regulations from start-up to commercialization while accelerating innovation and ensuring patient safety.
Siobhan Ashmore brings over 30 years of global experience across the life sciences industry, supporting organizations ranging from startups to multinational pharmaceutical, biotechnology, medical device, dietary supplement, and compounding pharmacies.
Having worked with leading life science companies including Pfizer, Amgen, Johnson & Johnson, Abbott, Ro Healthcare, and many others. Siobhan has extensive expertise in regulatory strategy, new product submissions, CMC, quality systems, manufacturing processes, formulation development, and global regulatory compliance. Her experience spans North America, Europe, and the Asia-Pacific region, enabling her to effectively navigate diverse regulatory environments and complex compliance challenges.
Throughout her career, Siobhan has successfully guided organizations through regulatory inspections, inspection readiness programs, FDA Form 483 observation responses, Warning Letter remediation, and Consent Decree compliance initiatives. She is widely recognized for her ability to strengthen quality systems, mitigate regulatory risk, and establish sustainable compliance frameworks across global operations.
Siobhan spent 10 years as a Global Auditor with Pfizer, where she developed deep expertise in quality assurance, auditing, and regulatory oversight within complex international organizations. She has also served on behalf of State Boards of Pharmacy as both a 503A and 503B Pharmacy Inspector, providing valuable governance, compliance, and regulatory enforcement expertise within the compounding pharmacy sector.
In addition to her regulatory and quality leadership experience, Siobhan serves as a trusted board-level advisor on risk management, compliance, corporate governance, and scalable growth strategies for emerging biotechnology and life sciences companies. She works closely with startup organizations to support enterprise value creation, operational scaling, investor readiness, digital transformation initiatives, AI governance frameworks, and global regulatory strategies that strengthen organizational resilience and build investor confidence.
Her broad industry experience, combined with a comprehensive understanding of regulatory requirements, quality systems, operational excellence, and strategic growth, enables her to help organizations achieve compliance objectives, enhance performance, accelerate innovation, and successfully navigate evolving global regulatory expectations.
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EDUCATION & CERTIFICATIONS
• BSc – Analytical Chemistry
• National Certificate in Management, Australia
• Qualified Person (QP) – Masters in Pharmaceutical Science (In Progress / On Hold)Certifications:
• Lead Auditor Training EU (1999)
• Global Corporate Auditor (Pfizer, 2002)
• Global Gallup Strengths Counselor (2023)Associations:
• Board Member – SOPPhC (Society of Pharmaceutical & Healthcare Compliance) (2025 -Present)
• Board Member – ASQ Board Member – Auditing
• Board Facilitator (5 Year Strategic Plan Build-out) ISPE Strategic Leader & Board Facilitator (5-Year Strategic Plan) Washington DC. (2023)
• PDA Guidance Document Contributor – Remote GMP/GDP Inspection Guidance
• Speaker – KENX, ISPE, University of Miami
• Author – Tablets & Capsules Magazine -
Executive Summary of Expertise:
• Experience with large established Pharmaceutical, Biotech, CGT, Medical Device, Dietary Supplement companies
• Experience with start-ups from regulatory submission to commercialization
• Experience with 503A and 503B compounding pharmacy compliance & inspection readiness
• Global regulatory submissions, including FDA, EMA, MHRA, TGA, and other international filings.
• Chemistry, Manufacturing & Controls (CMC) strategy and submission support
• Inspection readiness and quality and regulatory remediation. FDA Form 483, Warning Letter, Consent Decree, and Pre-Approval Inspection (PAI) remediation
• Quality Management System (QMS) design and implementation (Life Sciences)
• Digital Transformation, Data integrity, and Computer System Validation (CSV), including 21 CFR Part 11, EU Annex 11, and GAMP compliance.
• Sterile manufacturing and aseptic processing
• Technology transfer and New Product Introduction (NPI)
• Supplier qualification and global auditing programs
• Risk management and ICH Q9 implementation.
• Technical Transfers/Mergers, acquisitions, and post-acquisition integration
• Global Auditing
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