Lead Quality Assurance Director for Biologics Development

13 hours ago


Miami, United States Summittherapeutics Full time

Summit Therapeutics is seeking a seasoned Lead Quality Assurance Director to spearhead quality activities during clinical development and commercialization of drug candidates. This strategic role will be responsible for deviation resolutions, investigations, CAPAs, change controls batch record review, and the development of robust quality systems.

The ideal candidate will provide QA support in preparing quality sections of regulatory submissions and ensure compliance with ICH, FDA, EMA, and other global health authority regulations and industry standards.

Key Responsibilities
  • Quality System Development: Develop and implement GMP quality systems, including quality policies and procedures, to ensure compliance with applicable regulations.
  • Certificate of Analysis (CoA) Oversight: Provide sponsor oversight of Contract Manufacturing Organizations (CMO) for clinical and commercial manufacture.
  • GXP Compliance: Ensure GXP compliance for all vendors and CMOs and provide on-site oversight as needed.
  • Regulatory Submissions: Assist in preparing quality sections of regulatory submissions.
Requirements
  • Education: Bachelor's degree in chemistry, biochemistry, biotechnology, or related life sciences discipline; higher degree preferred.
  • Experience: Minimum 10+ years of relevant experience in GMP manufacturing requirements for clinical and commercial biologics.
  • Skills: Strong expertise and experience working with CMOs, designing and implementing quality systems and risk management tools, and leading/hosting US and international health authority inspections.

This role requires excellent communication skills, fluency in Mandarin is highly preferred, and ability to work efficiently in a fast-paced environment. The estimated annual salary for this position is approximately $120,000 - $180,000 based on industry standards and location considerations.



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