Interim GMP Readiness Lead

Our client is seeking an experienced Interim GMP Readiness Lead to prepare a pioneering production organisation for its first EU GMP Manufacturer’s Licence for a radionuclide precursor intended for use as an Active Pharmaceutical Ingredient (API). This role will focus on driving GMP readiness across facilities, quality systems, validation activities, manufacturing processes, and organisational capability, ensuring full compliance ahead of regulatory inspections and licensing activities.

The successful candidate will act as the key GMP authority within the programme, working across engineering, facility, validation, process development, and quality teams to ensure all GMP requirements are implemented, documented, and inspection-ready.

Main Responsibilities:

• Develop and implement the GMP readiness strategy to achieve the organisation’s first GMP Manufacturer’s Licence.
• Create, maintain, and drive an integrated GMP Readiness Master Plan.
• Act as the primary point of contact for GMP compliance across the programme.
• Identify compliance risks and implement effective mitigation strategies.
• Report progress, risks, and key decisions to senior management and steering committees.
• Ensure all GMP quality systems, procedures, and governance processes are established and operating effectively.
• Conduct GMP gap assessments against EU GMP requirements and relevant FDA regulations.
• Translate regulatory requirements into practical implementation plans across the organisation.
• Collaborate with engineering and facility teams to ensure GMP-compliant design, construction, qualification, and commissioning activities.
• Review qualification strategies, validation plans, commissioning documentation, and user requirements.
• Oversee qualification and validation programmes, including facilities, equipment, utilities, computerised systems, and manufacturing processes.
• Support technology transfer, process validation, and manufacturing readiness activities.
• Ensure GMP compliance of raw materials, production processes, release strategies, and supporting documentation.
• Verify that all required CMC documentation is complete and inspection-ready.
• Lead inspection readiness activities and organise mock inspections and readiness assessments.
• Coordinate preparation for EU GMP licensing inspections, FDA/cGMP readiness activities, and other regulatory inspections.
• Support responses to regulatory questions, observations, and inspection findings.

Key Skills & Experience:

• Minimum 15 years of experience within GMP-regulated pharmaceutical, biotechnology, or related manufacturing environments.
• Proven track record of obtaining an initial GMP licence or bringing a new GMP production facility into operation.
• Extensive knowledge of EU GMP regulations, ICH guidelines, FDA cGMP requirements, and Pharmaceutical Quality Systems.
• Strong experience in qualification, validation, and regulatory inspection programmes.
• Demonstrated success in leading large-scale GMP transformation, readiness, or compliance programmes.
• Excellent stakeholder management skills with the ability to engage effectively at executive, project, and operational levels.
• Experience managing complex, cross-functional projects involving engineering, quality, validation, and manufacturing teams.
• Fluent in Dutch and English.

Julija Jouffroy