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Pharmaceutical Quality Consulting

35+ Years of Pharmaceutical Quality & Auditing Expertise at Your Service.

Former GSK Global Supplier Quality Lead & Regulatory Inspection Expert offering specialized Auditing, Inspection Readiness, and GMP Training worldwide.

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“…your ability to face every situation with a smile, making even the busiest days feel lighter.”
Read what colleagues say
Portrait of Eliseo Di Giosaffatte
Years Experience
35+
Audits Executed
400+
Hosted Regulatory Inspections
40+
Countries Covered
20+

Services Offered

Independent expertise, tailored to your site.

For Big Pharma, Biopharma, CMOs and suppliers of raw materials, packaging and services to the pharmaceutical industry.

Auditing

Audit preparation, agenda definition, execution, report finalization and follow-up.

  • Suppliers
  • CMOs
  • Service providers
  • Labs
  • Pharma industries

Co-Auditing

Auditing side by side with your team to qualify your internal auditors.

  • Client auditors qualification
  • Shadow audits
  • Hands-on mentoring

Regulatory Inspection Readiness

Get your site and your people ready before the inspectors arrive.

  • Mock inspections
  • Inspection management training
  • GEMBA Walk

Training

Custom training tailored to your organization and your teams.

  • GMP Training
  • Audit techniques & behavior
  • Inspection Management
  • Co-Auditing for auditor qualification

What People Say About Me

Professionalism, mastery — and a smile.

“Thank you for your unique and creative way of communicating, always able to turn the most serious topic into something engaging and memorable. You were able to build genuine connections, and reminded us every day that, behind every job title and role, there are people first and foremost. In a world that often focuses on numbers, targets and deadlines, you have consistently shown that values are not just a detail, but the compass that guides us.”
“I always remember our audit, where your relaxed way of dealing with everything helped to keep the atmosphere positive, even in busy times and in complex situations…”
“Always smiling…”
“Thank you for being an exceptional manager and mentor of my career path. It has been a wonderful journey of learning, growth and development, both professionally and personally. Your expertise in auditing and compliance, combined with your sense of duty, leadership and humor, has inspired so many people! You have helped develop and guide countless colleagues, interns, and young professionals from around the world, leaving a lasting impact on their careers and lives.”
“Working with you has been a privilege, especially because we faced every situation with good humor, without ever losing professionalism…”
“Dear Eliseo, I will always hold you in my heart as an extremely competent colleague who taught me so much over these years during the audits I had the honor and pleasure of conducting with you, but above all as a truly wonderful human being. On life’s journey, it is not always a given to meet people as kind, competent, good-humored and open as you are. I wanted to tell you that you have been a colleague who played a vital role in my professional growth. I learned so much from you in the masterful way you conduct audits and handle quality matters, but above all, your wonderful humanity truly reached me. Thank you.”
“Thank you for your professionalism, your expertise, and your ability to face every situation with a smile, making even the busiest days feel lighter.”

My Key Expertise

Decades of hands-on quality leadership.

Quality Regulatory Requirements

A strong quality mindset built in Italian and European Quality departments, and first-hand knowledge of how regulators actually apply the rules.

Areas

  • GMP regulations
  • Aseptic & non-aseptic operations
  • Biotech & Pharma
  • Sterile primary glass containers

Quality Management System

Defining and restructuring quality systems, from a company’s first quality policies to global procedures tailored to each site’s needs.

Areas

  • QMS design & restructuring
  • Quality policies
  • Global procedures, local implementation
  • Site Master File

Regulatory Inspection Management

More than 40 regulatory inspections prepared and hosted, each followed by a CAPA plan developed and implemented.

Authorities from

  • USA (FDA)
  • Europe (EMA)
  • Italy
  • UK
  • France
  • Canada
  • Mexico
  • Brazil
  • Russia
  • China
  • South Korea
  • Thailand (HALAL)

Auditing & Supplier Management

400+ audits over 33 years, across the whole pharmaceutical supply chain.

Audited

  • Pharma companies & CMOs
  • APIs & chemicals
  • Animals & eggs
  • Glass primary containers
  • Printed packaging
  • Single-use systems
  • Gamma & EO sterilization
  • Calibration & laundry
  • Software development
  • Testing labs

Audited in

  • Italy
  • Europe
  • UK
  • USA
  • Mexico
  • Morocco
  • India
  • Russia
  • China
  • Japan
  • South Korea
  • Australia
  • New Zealand

My Story

A career built on rigorous compliance — and on people.

I was born in Pescara in 1961 and grew up by the sea — its autumn breeze is still what I miss most. At 18, I moved to Bologna to study Pharmaceutical Chemistry and graduated with the highest marks.

I began my career at Janssen, where I built a new Quality Assurance department and prepared the site for its first FDA pre-approval inspection, which it passed. I then moved to sterile manufacturing at Chiron in Siena, and through Novartis and GSK went from site compliance to the global supplier auditing team.

I started auditing while preparing for that first FDA inspection. It quickly became my favorite part of the job — and I never stopped until my retirement.

Behind every job title and role, there are people first and foremost.
Rigorous compliance delivered with approachability, mentorship, and good humor. Always with a smile.

My CV at a Glance

Four decades in pharmaceutical quality.

  1. 2018 – 2026 Global Supplier Quality Auditor GSK Vaccines
  2. 2011 – 2017 Supplier Quality Unit Manager Novartis Vaccines, then GSK Vaccines
  3. 2006 – 2011 Head of Compliance, Italy Novartis Vaccines & Diagnostics
  4. 2002 – 2006 Head of Corporate Regulatory Compliance, EU & ROW Chiron Corporation
  5. 1997 – 2002 TQM & Compliance Manager Chiron S.p.A., Siena
  6. 1987 – 1997 From Chemical Lab Head to QA Manager Janssen-Cilag, Latina
  7. 1985 Pharmaceutical Chemistry and Technology, 110/110 University of Bologna

Contact

Let's talk about your quality challenges.

Whether you need an audit, a mock inspection or tailored GMP training, I would be glad to hear from you.

Schedule a consultation

Tell me about your needs and I will get back to you.