Inspection Readiness Consultant – EU Regulatory Inspections
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We are seeking an experienced Inspection Readiness Consultant to support pharmaceutical, biotechnology or clinical research organisations in preparing for inspections by the European Medicines Agency (EMA) and European national competent authorities.
The consultant will assess regulatory compliance, identify and address quality system gaps, prepare personnel for inspection activities and provide practical support before, during and after regulatory inspections.
Working across relevant regulated areas, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP) and Good Distribution Practice (GDP), you will help organisations strengthen inspection preparedness, manage compliance risks and establish sustainable inspection readiness processes.
This role requires strong knowledge of the European regulatory environment, practical inspection experience and the ability to work confidently with senior leaders, subject matter experts and cross-functional teams in time-sensitive situations.
The Role
Key responsibilities
Inspection readiness strategy and planning
- Develop and implement risk-based inspection readiness strategies and plans aligned with applicable European regulatory requirements.
- Establish clear governance arrangements, responsibilities and escalation processes for inspection preparation and execution.
- Develop and maintain readiness plans, including milestones, timelines, action owners and progress monitoring.
- Coordinate cross-functional activities to ensure inspection preparation is completed effectively and within agreed timescales.
Compliance assessments and mock inspections
- Conduct inspection readiness assessments, mock inspections and gap analyses against applicable European legislation, regulatory guidance and relevant industry standards.
- Review quality management systems, standard operating procedures, clinical trial documentation, pharmacovigilance records and regulatory submission information, as relevant to the scope of the engagement.
- Assess documentation completeness, traceability, compliance and data integrity.
- Identify and prioritise compliance gaps according to risk, recommending appropriate remediation actions.
- Develop, review and monitor corrective and preventive action (CAPA) plans, including responsibilities, target dates and effectiveness checks.
Pre-inspection preparation
- Prepare sponsor organisations, clinical sites, contract research organisations (CROs), vendors and other relevant teams for regulatory inspections.
- Assess organisational, facility, documentation and data readiness.
- Coordinate inspection logistics, including inspection rooms, document request management, retrieval processes and support arrangements.
- Develop inspection briefing materials, key messages, process summaries and subject matter expert preparation documents.
- Support preparation for routine, for-cause and pre-approval inspections, including inspections coordinated by European regulatory authorities.
- Ensure relevant personnel understand their roles, responsibilities and escalation routes during an inspection.
Training and coaching
- Deliver inspection readiness training and simulated interview sessions for senior leaders, subject matter experts and other relevant personnel.
- Prepare key personnel for inspector interviews, including individuals with designated quality, safety, manufacturing or distribution responsibilities, as applicable.
- Coach teams on effective communication, inspection conduct, document handling and response techniques.
- Build confidence and consistency in inspection responses while reinforcing the importance of accuracy, transparency and data integrity.
Inspection support
- Act as inspection coordinator or provide expert support to the designated inspection lead.
- Coordinate and track inspector requests, document submissions, emerging observations and outstanding actions.
- Facilitate communication between inspectors and internal subject matter experts.
- Support daily inspection debriefs, issue escalation and assessment of potential compliance risks.
- Advise on responses to inspector questions and emerging findings, ensuring responses are accurate, evidence-based and appropriately reviewed.
Post-inspection management
- Support the preparation and review of responses to inspection observations, findings and formal regulatory correspondence.
- Develop and oversee remediation plans, ensuring actions address underlying causes and are completed within agreed timelines.
- Track CAPA implementation and support effectiveness verification.
- Facilitate lessons-learned reviews and incorporate findings into future inspection readiness activities.
- Recommend improvements to quality systems, documentation practices and inspection management processes.
Continuous improvement
- Monitor relevant regulatory developments, inspection trends and published guidance affecting European regulatory inspections.
- Advise on quality metrics, key performance indicators and reporting tools to monitor inspection readiness.
- Identify opportunities to improve inspection preparation, governance, compliance oversight and cross-functional collaboration.
- Support the development of a sustainable, proactive inspection readiness culture.
Requirements
About you
You are an experienced quality assurance or regulatory compliance professional with a strong track record supporting regulatory inspections in the pharmaceutical, biotechnology or contract research sectors.
You combine detailed regulatory knowledge with practical experience of inspection preparation, gap assessment, remediation and stakeholder coaching. You are organised, analytical and confident working with senior stakeholders, while remaining composed and decisive under pressure.
Essential qualifications and experience
- A bachelor's degree in life sciences, pharmacy or a related discipline; an advanced degree is desirable.
- At least eight years of experience in the pharmaceutical, biotechnology or CRO industry, including a minimum of five years in quality assurance, regulatory compliance or inspection-related activities.
- Demonstrable experience supporting or leading inspections conducted by the EMA and/or European national competent authorities.
- Practical experience conducting mock inspections, performing compliance gap assessments and managing CAPA activities.
- Strong working knowledge of at least one relevant regulated discipline: GCP, GMP, GVP, GLP or GDP.
- Good understanding of European regulatory requirements and regulatory inspection processes.
- Familiarity with relevant ICH guidelines, the EU Clinical Trials Regulation, the Clinical Trials Information System (CTIS), and recognised data integrity principles, including ALCOA+.
- Experience reviewing quality systems, procedures, controlled documentation and supporting evidence for inspection readiness.
- Excellent written and verbal communication skills, including the ability to brief senior stakeholders and engage effectively with inspectors.
- Strong project management, planning and stakeholder coordination skills.
- The ability to manage competing priorities, identify emerging risks and make sound decisions in a demanding regulatory environment.
Desirable experience
- Previous experience as a regulatory inspector or within a health authority.
- Experience supporting inspections conducted by the US Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA) or other international regulatory authorities.
- A recognised auditing or quality assurance qualification, such as ASQ Certified Quality Auditor (CQA), RQAP-GCP or an IRCA-recognised qualification.
- Experience working with advanced therapy medicinal products (ATMPs), biologics or complex clinical trial designs.
- Additional European language skills.
- Experience with computerised system validation, electronic Trial Master Files (eTMF) or other regulated electronic systems.
How to Apply
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