Regulatory Compliance Specialist for Outsourced Testing
1 week ago
We are seeking an experienced Regulatory Compliance Specialist to join our team at Direct Biologics, a rapidly growing biotechnology company specializing in advanced regenerative medicine therapies.
Job SummaryThe successful candidate will play a crucial role in ensuring the safety, efficacy, and quality of our early to late-stage products through effective management of outsourced testing. This position requires strong technical knowledge of analytical testing in highly regulated environments and excellent attention to detail.
Responsibilities- Manage drug substance, drug product, and raw material testing at external contract testing laboratories for a range of analytical techniques.
- Ensure compliance with all applicable regulatory guidelines and standards, including FDA requirements.
- Drive internal cross-functional teams for the evaluation, documentation, and timely response to investigations and deviations generated by outsourced testing laboratories.
- Lead cGMP activities to improve existing sampling plans and create new sampling plans as needed.
- Plan for future manufacturing campaigns' testing needs and collaborate with vendors for successful timeline adherence.
- Bachelor's degree in Biotechnology, biomedical engineering, cell and molecular biology, biochemistry, or other similar biology-related majors.
- Advanced degree preferred.
- Minimum of 5 years of experience in a Quality Control Management role within the pharmaceutical or biotechnology industry with outsourced GMP analytical product testing.
- A competitive salary range of $120,000 - $160,000 per year, depending on experience.
- Health Care Plan (Medical, Dental & Vision).
- Company 401k match up to 4%.
- Paid Time Off (Vacation & Sick).
- Holidays.
- Stock Option.
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