Operational Guide to the Role of the QA Manager in the Pharmaceutical Industry
Operational Guide to the Role of the QA Manager in the Pharmaceutical Industry
A practical, concrete, and audit-defensible guide for professionals who hold (or aspire to hold) the role of QA Manager in the pharmaceutical sector. Based on real-world experience from EMA, FDA, and AIFA inspections, concrete case studies, and ready-to-use operational tools.
WHY THIS GUIDE IS DIFFERENT
This is not just another theoretical GMP guide.
It is an operational guide, built around the way inspectors think and how QA Managers actually work in day-to-day practice.
Version 2.0 has been fully updated to reflect:
- the evolution of EU GMP
- the risk-based approach (ICH Q9 / Q10)
- the increased focus on data integrity, audit readiness, and defensible decision-making
- the real impact of digitalization, KPIs, and Quality 4.0
WHO THIS GUIDE IS FOR
This guide is designed for:
- QA Managers / QA Responsibles
- Senior QA Specialists
- Qualified Persons (QP)
- Site Quality Managers
- GMP professionals aiming to grow into leadership and responsibility roles
It is ideal both for those already in the role and for those who want to prepare in a serious, practical, and concrete way.
WHAT YOU WILL FIND IN THE GUIDE
✔️ Audit-oriented structure
Each chapter follows this framework:
- Real-world context
- What the inspector expects
- Common mistakes to avoid
- Operational best practices
- Practical examples and simulated cases
- Typical audit questions
✔️ All pillars of the QA role
- Pharmaceutical Quality System (ICH Q10)
- Deviations, CAPA, and Change Control
- Quality Risk Management (ICH Q9 / Q9 R1)
- Supplier management and GMP outsourcing
- Manufacturing, QC, and batch release
- Data Integrity & computerized systems
- Internal audits, regulatory inspections, and customer audits
- Quality and performance KPIs
- Quality culture and personnel training
✔️ Focus on “defensible” decisions
The guide teaches you how to make decisions that stand up to inspectors—not just what the regulations say.
OPERATIONAL APPENDICES (ADDED VALUE)
Included in the guide are ready-to-use templates and tools, such as:
- QA Manager Responsibility Matrix
- Deviation Assessment Template
- CAPA Effectiveness Checklist
- Change Control Decision Tree
- Audit Readiness Checklist
- Inspection Day Playbook
- QA KPI Dashboard Structure
👉 Materials that can be immediately implemented within your quality system.
Format: Professional PDF
Length: 125 pages
Updated: February 2026
Available languages: ITA – ENG
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HAVE QUESTIONS? CHECK OUT OUR FAQS
What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.