Regulatory Assurance Specialist
Há 7 horas
Job Title: Regulatory Assurance Specialist Job Description This is a critical role in supporting ongoing manufacturing campaigns, batch release, and ensuring timely resolution of quality events. The Regulatory Assurance Specialist will provide oversight of Contract Development and Manufacturing Organizations (CDMOs) and testing laboratories to ensure compliance with cGMP, regulatory requirements, and company quality standards. Key responsibilities include reviewing and approving deviations, out-of-specification investigations, CAPAs, and change controls from CDMOs and external testing laboratories, as well as monitoring manufacturing campaigns, production activities, and resolving issues during routine manufacturing. Additionally, the Regulatory Assurance Specialist will review and approve QC/analytical results and certificates of analysis from CDMOs/external labs, and perform GMP reviews of incoming documentation (batch records, test data, release packages). Excellent communication and problem-solving skills are required for this role, which involves collaboration with internal cross-functional teams (QA, QC, Supply Chain, Regulatory, CMC) to ensure readiness for release and regulatory filings, as well as supporting audit readiness activities for Regulatory Authority inspections. Required Skills and Qualifications Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Engineering, or related discipline. 3 - 5 years of QA experience in the biopharmaceutical or cell/gene therapy industry. Strong knowledge of cGMP, ICH Q7/Q10, FDA 21 CFR Parts 210/211. Experience with CDMO oversight, lot release, and deviation management. Excellent communication and problem-solving skills. About Nexcella Inc. Nexcella Inc. is a subsidiary of Immix Biopharma Inc. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T cell therapy NXC-201 with a digital filter that filters out non-specific activation. NXC-201 is being evaluated in a US multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 with a registrational design. Interim results were presented at ASCO 2025. NXC-201 has been awarded Regenerative Medicine Advanced Therapy by the US FDA and Orphan Drug Designation by FDA and in the EU by the EMA.
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Quality Assurance Specialist
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Belo Horizonte, MG, Brasil beBeeQuality Tempo inteiroQuality Assurance Specialist Job Summary: We are seeking a highly skilled and detail-oriented Quality Assurance Specialist to join our team.
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Quality Assurance Specialist
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Belo Horizonte, Brasil beBeeQuality Tempo inteiroQuality Assurance Specialist Job Summary: We are seeking a highly skilled and detail-oriented Quality Assurance Specialist to join our team.
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