Senior Quality Assurance Director
4 days ago
We are seeking an experienced QA professional to support and evolve the quality management systems at our ProtaGene US Site.
This individual will work in a fast-paced, high-growth CRO environment serving leading pharma in biologic development and cell & gene therapy.
This is a unique opportunity to join a dynamic team and play a key role in supporting the growth of the Quality function.
The ideal candidate will have a strong quality awareness and ability to apply quality knowledge in practical work.
Responsibilities include driving expansion of the Quality Management System(s), leading and participating in third-party and regulatory audits, overseeing qualification of equipment and systems, and organizing employee training.
The Quality Assurance Manager will also be responsible for creating, revising, and reviewing documents, overseeing and developing CAPA, deviation, risk analysis, and change control management, and communicating with domestic and international pharmaceutical and life science customers and auditors.
Additionally, the Quality Systems Specialist will conduct QA in the company's programs, ensuring Data Integrity in processes, data packages, and reports to external pharma and gene therapy partners.
Key qualifications include a scientific or engineering degree, minimum of 5+ years of progressive Quality experience in a regulated environment, and experience in preparation and participation in FDA inspections.
The ideal candidate will also have experience leading the accreditation/certification procedures for CAP/CLIA, strong quality awareness, and ability to apply quality knowledge in practical work.
ProtaGene US, Inc is a world-leading analytical CRO partner for the global biopharmaceutical, gene, and cell therapy industries.
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