Position Summary:
- Support the development and execution of a healthcare compliance program.
- Lead key elements of a pre-commercial compliance program.
- Support future field engagements following potential product approval.
Key Responsibilities:
- Develop policies and procedures that provide appropriate guidance to employees.
- Conduct regular compliance audits and risk assessments.
- Stay current with industry trends and regulatory changes.
Required Experience:
- Possess a minimum of 6 years of experience in compliance within the pharmaceutical or biotech industry.
- Have strong knowledge of FDA regulations and GxP standards.
- Demonstrate the ability to manage multiple tasks independently and simultaneously.
Orca Bio
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. They aim to provide significantly better survival rates with dramatically fewer risks. They have a start-up culture of camaraderie and leadership by example.