Associate Director of Quality Assurance - Quality Assurance

CyberCoders

  • New York City, NY
  • $166,000-200,000 per year
  • Permanent
  • Full-time
  • 21 days ago
We are looking for a highly skilled Associate Director, CMC Quality Assurance.We are a very accomplished team of industry experts with a mission to thoughtfully develop transformative medicines to improve patients lives with life-altering immune and inflammatory diseases. Our lead program has completed multiple phases 1 and Phase 2 clinical trials and we just launched out Phase 2b trial in thyroid Eye Disease in 2023 and Phase 2 clinical trial in cardiovascular disease in Q2 2024. We are looking to start our Phase 3 Clinical trial in TED later this year.We are looking for an Associate Director, CMC QA will report directly to the Director of CMC Quality Assurance and will be responsible for the daily CMC operations included those performed at the CMO and CTLs that manufacture our products. You will also provide strategic leadership in support of continuous improvement, risk mitigation, and data integrity pertaining to the product manufacturing and quality management system to ensure a culture of quality and complianceWhat you will be doing:
  • Provide strategic leadership to develop, establish, and maintain the QA programs, policies, and procedures to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.
  • Coordinate investigations with vendors and interdepartmental teams to resolve potential quality issues, mitigate risks, and ensure that appropriate corrective/preventative actions are identified and implemented.
  • Support the management and continuous improvement of quality systems, including but not limited to supplier qualification, change management, product complaint management, quality management review, and deviation/CAPA management.
Must Have:
  • BS/BA degree with a minimum of ten years experience or, MS/MA with 7 years of experience.
  • Experience with 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 4 (Combination Products)
  • Minimum 3 years of experience in CMO oversight is required
  • Working knowledge of clinical manufacturing and quality processes, including US and EU regulations and ICH guidelines affecting the pharmaceutical industry
Base Salary Range: $166k - $200kBenefitsApplicants must be authorized to work in the U.S.Additional ways to applyPreferred Skills

CyberCoders