Regulatory Compliance Specialist for Outsourced Testing

1 week ago


Poway, California, United States Direct Biologics Full time
Job Overview

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 Summary

The 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
  1. Manage drug substance, drug product, and raw material testing at external contract testing laboratories for a range of analytical techniques.
  2. Ensure compliance with all applicable regulatory guidelines and standards, including FDA requirements.
  3. Drive internal cross-functional teams for the evaluation, documentation, and timely response to investigations and deviations generated by outsourced testing laboratories.
  4. Lead cGMP activities to improve existing sampling plans and create new sampling plans as needed.
  5. Plan for future manufacturing campaigns' testing needs and collaborate with vendors for successful timeline adherence.
Requirements
  • 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.
What We Offer
  • 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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