What are the responsibilities and job description for the Regulatory Compliance Expert - Suppliers position at RoslinCT?
RoslinCT is a pioneering organization in cell and gene therapy contract development and manufacturing. We believe in empowering our employees to grow professionally, develop their skills, and contribute to groundbreaking therapies.
We adhere to a set of core values that guide our actions: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. These values create a collaborative and inclusive work environment where our team members can thrive.
The Senior Supplier Quality Assurance Specialist will be responsible for:
- Ensuring compliance with FDA regulations and internal SOPs.
- Managing supplier documentation and performance monitoring.
- Leading corrective actions based on supplier audits.
To excel in this role, you should have:
- A degree in science, engineering, or a related field.
- At least 5 years of experience in a regulated industry, preferably in biopharmaceuticals or cell therapy.
- Knowledge of supplier quality management principles.
- Familiarity with US and EU cGMP regulations and guidance.
We offer a dynamic work environment, opportunities for growth, and a competitive benefits package to support your career development.
