For a strategic program within an organization, focused on the production of radionuclide precursors, we are looking for a highly experienced GMP Readiness Lead. The assignment aims to fully prepare the organization, facilities, processes, and quality systems for a first GMP license as a manufacturer of a radionuclide precursor, for both an Active Pharmaceutical Ingredient (API) and potential product registration.
The initial focus is on the European market (EU GMP), followed by preparation for the American market (FDA/cGMP). The GMP Readiness Lead plays a key role between ongoing facility, engineering, process development, validation, and quality projects, ensuring that all GMP-related requirements are implemented and documented in a timely, complete, and demonstrable manner.
What you do
- Develop and execute the GMP Readiness strategy towards the first manufacturer license.
- Establish and maintain an integrated GMP Readiness Master Plan.
- Act as a content and strategic point of contact for GMP compliance within the program.
- Identify compliance risks and implement mitigating measures.
- Report progress, risks, and decision points to senior management and steering committees.
- Perform GMP-gap assessments against EU GMP and relevant FDA requirements.
- Translate regulations into practical implementation within the organization.
- Collaborate with facility and engineering projects to ensure GMP-compliant design, realization, and qualification.
- Review URSs, qualification strategies, validation plans, and commissioning documentation.
- Oversee timely execution of DQ, IQ, OQ, PQ, Cleaning Validation, Computer System Validation (CSV), Environmental Monitoring, and Utility Qualification.
- Ensure GMP readiness of production processes.
- Support technology transfer and process validation.
- Monitor GMP aspects related to raw materials, radionuclide-specific processes, and release strategies.
- Verify that necessary CMC-related documentation is available for registration and inspection purposes.
- Lead inspection readiness activities towards competent authorities.
- Organize mock inspections and readiness assessments.
- Coordinate inspection preparations for EU GMP manufacturer license, FDA/cGMP readiness, and any other relevant international authorities.
- Support in responding to inspection findings and regulatory questions.
Deliverables.
- Facilities, utilities, equipment, and processes GMP-qualified.
- The Pharmaceutical Quality System fully operational.
- All critical GMP documentation available and approved.
- Organization, personnel, and suppliers GMP-ready.
- The facility inspection-ready for obtaining the first EU GMP manufacturer license.
- A roadmap and readiness plan available for FDA/cGMP and US market access.
Profile
- Strategically strong and hands-on at the same time.
- Results-oriented with a focus on licensing and inspection readiness.
- Decisive and able to connect conflicting interests.
- A natural leader who can align multidisciplinary teams on GMP objectives.
- Strong in risk analysis, prioritization, and execution.
What they ask
- Minimum 15 years of experience within GMP-regulated pharmaceutical or biotech environments.
- Excellent command of Dutch and English.
- Completed relevant bachelor's or master's degree, or equivalent.
Desired.
- Demonstrable experience in obtaining a first GMP license or making new production facilities operationally ready.
- In-depth knowledge of EU GMP, ICH guidelines, FDA cGMP, Pharmaceutical Quality Systems.
- Experience in a senior program, project, or transformation leadership role.
How to apply
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