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For an important multinaltional company leader in the pharmaceutical industry, we are recruiting for joining their team dedicated to advancing innovative cell therapy treatments a position as :
Cell Therapy Compliance Specialist 100% H/F
Reporting directly to the Director of Cell Therapy Compliance, the Cell Therapy Compliance Specialist will play a critical role in ensuring compliance with regulatory and GMP requirements for cell therapy products. You will collaborate with Global Process Owners and cell therapy leaders to develop and revise procedures and forms related to cell therapy disposition, supporting product launches in new markets and ensuring operational excellence.
Cell Therapy Compliance Specialist 100% H/F
Reporting directly to the Director of Cell Therapy Compliance, the Cell Therapy Compliance Specialist will play a critical role in ensuring compliance with regulatory and GMP requirements for cell therapy products. You will collaborate with Global Process Owners and cell therapy leaders to develop and revise procedures and forms related to cell therapy disposition, supporting product launches in new markets and ensuring operational excellence.
Description du poste
- Collaborate with Global Process Owners and leadership teams to create, review, and update procedures and forms related to cell therapy disposition.
- Support documentation processes essential for launching cell therapy products in new markets.
- Ensure all documentation aligns with GMP standards and regulatory requirements.
- Work across teams in a matrix environment to build strong relationships and contribute to compliance-related initiatives.
- Provide innovative, compliant solutions to support continuous improvement in compliance processes.
Profil attendu
- Bachelor's degree in Natural Sciences (e.g., Chemistry, Pharmacy, Biology, Chemical Engineering, or a related pharmaceutical science).
- 3–5+ years of experience in the biopharmaceutical industry, preferably in manufacturing, quality, technical, or regulatory roles.
- Strong understanding of quality systems principles and GMP applications in the biopharmaceutical industry.
- Experience interacting with regulatory health authorities is a plus.
- Ability to analyze situations critically and make sound, risk-based decisions under dynamic conditions.
- Excellent written and verbal communication skills.
- Demonstrated ability to work independently and collaboratively in a matrix environment.
- Proactive mindset with a focus on innovation, transparency, and reliability.
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