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Vice President Of Quality
hace 2 meses
Vice President of Quality About the Company Innovative biotechnology (BioTech) company specializing in mRNA therapeutics
Industry
Pharmaceuticals
Type
Privately Held
Founded
2017
Employees
51-200
Categories BiotechnologyManufacturingPharmaceuticalsMedicineChemical ProductsAcademic ResearchLaboratory Services About the Role The Company is seeking a Vice President of Quality to lead and strategically direct QA compliance for all GXP activities. The successful candidate will be responsible for developing, maintaining, and continually improving quality operations, the quality management system, the quality assurance program, and the training program. This role involves providing overall quality and compliance oversight for the manufacturing and supply chain process to support the company's clinical campaigns. The Vice President of Quality will also be tasked with building the quality organization, establishing and maintaining GMP compliance, and managing the audit program against GXP standards and regulatory requirements.
Applicants for the Vice President of Quality position at the company should have a B.S. or advanced degree with at least 10 years of industrial experience in a GMP quality function within a biotechnology or pharmaceutical organization. A strong understanding of quality principles and GMP/ICH/FDA regulations is essential, with a preference for those with experience in quality operations for mRNA or nucleic acid-based products. The role requires technical knowledge of analytical method qualification, process validation, and product specifications, as well as proficiency in Quality by Design principles. The ideal candidate will be independently motivated, detail-oriented, and possess excellent problem-solving and organizational skills, with the ability to multitask in a fast-paced environment.
Hiring Manager Title
President, Co-Founder & Head of R&D
Travel Percent
Less than 10%
Functions EngineeringMedical Care/Hospital Administration
