The Director of Quality Assurance will lead the quality activities at Summit during clinical development and commercialization of drug candidates. Responsible for deviation resolutions, investigations, CAPAs, change controls batch record review, and development of robust quality systems. The Director of Quality Assurance will provide QA support in the preparation of quality sections of regulatory submissions.
Role and Responsibilities:
- Develop and implement GMP quality systems including all quality policies and procedures pertaining to GMP manufacture and testing in accordance with ICH, FDA, EMA and other global health authority regulations and industry standards.
- Responsible for providing sponsor oversight of Contract Manufacturing Organizations (CMO) to support clinical and commercial manufacture.
- Provide 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 existing policies and procedures, and develop new and enhanced policies that ensure compliance to regulations.
- Write, revise, review and/or approve SOPs, 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.
- All other duties as assigned.
Experience, Education and Specialized Knowledge and Skills:
- 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 with the ability 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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