Director of Quality Assurance and Compliance
4 weeks ago
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.
- 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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