Regulatory Compliance Officer
6 days ago
ZipRecruiter is a leading recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. We're looking for a highly skilled Quality Assurance Lead to join our team.
In this role, you will be responsible for ensuring compliance with regulatory requirements and industry standards, developing and implementing quality management systems, and managing the integration of quality processes between sites and partner companies.
You will also collaborate with the Procurement team to agree on the necessary level of quality for prototype and production suppliers and engage with key suppliers to ensure they comply.
Key Responsibilities:
- Assisted with transitioning processes from 9001 to 13485
- Developed procedures for key activities such as Risk Management, Design Review, and Test Strategy (exact assignment TBD depending on where we have got to)
- Rolled out processes, ensuring staff were trained and assisted them in following the procedures
- Managed the integration of quality processes between sites and partner companies (coordinating documentation requirements, etc.), including setting scope for audits of partner companies
- Collaborated with the Procurement team to agree on the necessary level of quality for prototype and production suppliers, and to engage with key suppliers to ensure they comply
Estimated Salary: $90,000 - $110,000 per annum
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