Director of Quality Assurance and Compliance

2 weeks ago

Menlo Park, California, United States Summittherapeutics Full time
Job Title: Director of Quality Assurance and Compliance

Summit Therapeutics is seeking a highly experienced Director of Quality Assurance and Compliance to lead our quality activities during clinical development and commercialization of drug candidates.

Key Responsibilities:
  • Develop and implement GMP quality systems, including quality policies and procedures, in accordance with ICH, FDA, EMA, and other global health authority regulations and industry standards.
  • Provide sponsor oversight of Contract Manufacturing Organizations (CMOs) to support clinical and commercial manufacture.
  • Ensure GXP compliance oversight for all vendors and CMOs, and provide on-site oversight of CMO operations as needed.
  • Lead and ensure GMP inspection readiness activities for Summit and external CMOs.
  • Establish internal QA batch review and release processes for batch disposition of drug products, as required and in compliance with applicable regulations.
  • Supervise and guide internal audits of departments and processes.
  • Review and develop new and enhanced policies to ensure compliance with regulations.
  • Write, revise, review, and/or approve SOPs and controlled documents to ensure compliance with all applicable regulations.
  • Drive cross-functional collaboration and alignment with other departments and stakeholders to achieve quality and compliance objectives.
  • Develop a robust quality system and foster best practices across the organization.
  • Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met.
  • Establish and maintain performance metrics.
Requirements:
  • Bachelor's degree in chemistry, biochemistry, biotechnology, or other related life sciences discipline. Higher degree preferred.
  • Minimum of 10+ years of relevant experience.
  • Strong expertise and experience with GMP manufacturing requirements for clinical and commercial biologics.
  • Demonstrated ability working with and managing CMOs.
  • Experience in designing and implementing quality systems and risk management tools.
  • Experience leading/hosting US and international health authority inspections.
  • Experience managing complex business relationships with QPs.
  • Excellent communication skills, both oral and written.
  • Fluency in Mandarin is highly preferred.
  • Ability to work in a fast-paced environment and efficiently manage QA projects and timelines.
  • Experience in working independently on multiple programs in a fast-paced environment and able to balance changing priorities.
  • Attention to detail, accuracy, and thoroughness expected in all aspects of work.
  • Self-motivated with a strong sense of work ethic.
  • Excellent interpersonal skills and collaborative.

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