Summit Therapeutics
Director, Quality Assurance
Summit Therapeutics, Menlo Park, California, United States, 94029
Director, Quality Assurance
Overview of Role:
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 standardsResponsible 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 neededLead and ensure GMP inspection readiness activities for Summit and external CMOsEstablish internal QA batch review and release processes for batch disposition of drug products as required and in compliance with applicable regulationsSupervise and guide internal audits of departments and processesReview existing policies and procedures, and develop new and enhanced policies that ensure compliance to regulationsWrite, revise, review and/or approve SOPs, controlled documents to ensure compliance with all applicable regulationsDrive cross-functional collaboration and alignment with other departments, and stakeholders to achieve quality and compliance objectivesDevelops a robust quality system and fosters best practices across the organizationEnsure issues are identified and managed through to resolution in a timely manner and deliverables are met.Establish and maintain performance metricsAll other duties as assignedExperience, 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 biologicsDemonstrated ability working with and managing CMOsExperience in designing and implementing quality systems and risk management toolsExperience leading/hosting US and international health authority inspectionsExperience managing complex business relationships with QPsExcellent communication skills both oral and written.Fluency is mandarin is highly preferredAbility to work in a fast-paced environment and efficiently manage QA projects and timelinesExperience in working independently on multiple programs in a fast-paced environment with and able to balance changing prioritiesAttention to detail, accuracy, and thoroughness expected in all aspects of workSelf-motivated with a strong sense of work ethicExcellent interpersonal skills and collaborative
The pay range for this role is $190,000-$210,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's human resources department to obtain prior written authorization before referring any candidates to Summit.
Overview of Role:
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 standardsResponsible 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 neededLead and ensure GMP inspection readiness activities for Summit and external CMOsEstablish internal QA batch review and release processes for batch disposition of drug products as required and in compliance with applicable regulationsSupervise and guide internal audits of departments and processesReview existing policies and procedures, and develop new and enhanced policies that ensure compliance to regulationsWrite, revise, review and/or approve SOPs, controlled documents to ensure compliance with all applicable regulationsDrive cross-functional collaboration and alignment with other departments, and stakeholders to achieve quality and compliance objectivesDevelops a robust quality system and fosters best practices across the organizationEnsure issues are identified and managed through to resolution in a timely manner and deliverables are met.Establish and maintain performance metricsAll other duties as assignedExperience, 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 biologicsDemonstrated ability working with and managing CMOsExperience in designing and implementing quality systems and risk management toolsExperience leading/hosting US and international health authority inspectionsExperience managing complex business relationships with QPsExcellent communication skills both oral and written.Fluency is mandarin is highly preferredAbility to work in a fast-paced environment and efficiently manage QA projects and timelinesExperience in working independently on multiple programs in a fast-paced environment with and able to balance changing prioritiesAttention to detail, accuracy, and thoroughness expected in all aspects of workSelf-motivated with a strong sense of work ethicExcellent interpersonal skills and collaborative
The pay range for this role is $190,000-$210,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's human resources department to obtain prior written authorization before referring any candidates to Summit.