Inspection Readiness Manager
Inspection Readiness Manager – Sterile Pharmaceuticals
Location: Pau, South West France
Contract type: Permanent
Industry: Pharmaceutical Manufacturing
Function: Quality Assurance / Regulatory Compliance
The Opportunity
A leading pharmaceutical contract manufacturer based in the South West of France is looking for an experienced Inspection Readiness Manager to take ownership of their site-wide regulatory inspection preparation programme.
This is a high-impact, cross-functional leadership role, sitting at the heart of quality operations and working directly with senior stakeholders across QA, production, and regulatory affairs. You will define the strategy, drive the execution, and prepare the organisation to face regulatory inspections from the ANSM, FDA, PMDA, and EMA with confidence.
What You Will Be Doing
- Defining and leading the global inspection readiness strategy for the site
- Building, managing, and tracking the CAPA readiness plan, ensuring critical actions are prioritised and closed on time
- Identifying and addressing high-risk areas: aseptic processes, data integrity, maintenance, and contamination control
- Facilitating steering committees (COPIL) and reporting to senior leadership on readiness status and KPIs
- Coaching and preparing teams on inspector-facing behaviour and GMP posture
- Coordinating across QA, production, validation, and CQ to ensure full site alignment
- Driving continuous improvement in aseptic practices and GMP compliance
What We Are Looking For
- Bac+5 in pharmacy, engineering, or a related scientific discipline
- 8–12 years of experience in the sterile pharmaceutical industry
- Proven track record managing or supporting regulatory inspections (ANSM, FDA, EMA, or PMDA)
- Deep expertise in GMP Annex 1, aseptic processes, and data integrity (ALCOA+)
- Experience leading cross-functional projects and steering committees
- Strong coaching and communication skills, able to prepare teams under pressure
- Fluent French; professional English an advantage