Director, Quality Assurance
Director, Quality Assurance
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$ 186000 - 233000
1 Vacancy
Job Description
About Summit:
Ivonescimab known as SMT112 is a novel potential first-in-class investigational
bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.
Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC) with three active Phase III trials:
HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g. osimertinib).
HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.
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 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
- Develops a robust quality system and fosters 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:
- Bachelors 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 is 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 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
The pay range for this role is $186000-$233000 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.
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 Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Director
Employment Type
Full-Time
