Quality Specialist

Responsibilities: 

• Provide quality oversight for gene therapy manufacturing operations, including internal production and external suppliers.
• Support change control assessments, investigations, and CAPA processes to ensure compliance with regulatory requirements.
• Review and approve GMP documentation, such as batch records, deviation reports, and validation protocols.
• Conduct root cause analyses and product impact assessments for deviations and non-conformances.
• Monitor and maintain quality metrics to ensure efficient and timely product release.
• Identify potential risks and drive mitigation strategies to enhance manufacturing and quality processes.

Qualifications:

• Bachelor’s degree in a scientific or allied health field (or equivalent experience).
• 3+ years of GMP quality experience in biologics, cell therapy, or gene therapy manufacturing.
• Strong understanding of change controls, CAPAs, and root cause analysis methodologies.
• Familiarity with cGMP requirements for advanced therapies (gene therapy, viral vectors, or biologics).
• Excellent communication and collaboration skills to work cross-functionally with manufacturing and regulatory teams.
• Experience in viral vector production, cell culture, or nucleic acid-based therapeutics.
• Knowledge of regulatory expectations for ATMPs (Advanced Therapy Medicinal Products).
• Familiarity with ICH, FDA, and EMA guidelines for gene therapy manufacturing.