--- title: 'Manager, Quality Assurance at Summit Therapeutics' canonical: 'https://feeny.ai/job/manager-quality-assurance-summit-therapeutics-princeton-ev9058f68c7c' type: 'job' last_seen: '2026-11-06' --- # Manager, Quality Assurance at Summit Therapeutics - **Company:** Summit Therapeutics - **Location:** Princeton, NJ - **Compensation:** $139k–$163k - **Posted:** 2026-10-20 - **Last confirmed live:** 2026-11-06 - **Apply:** https://job-boards.greenhouse.io/summittherapeutics/jobs/4450807009 ## Job description About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) - HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. - HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. - HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) - HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Manager of QA reports to the Director of QA and will provide quality oversight for the Product Complaint program. This will include investigation resolution for complaints associated with clinical and commercial material. The Manager will also be responsible for ensuring Summit departments and systems are inspection ready by way of conducting internal and external audits,  supporting inspection readiness activities, and authoring and updating internal procedures and Quality Technical Agreements (QTA). Role and Responsibilities: - Serve as the liaison for our commercial product complaint call center and also manage clinical product complaints. - Ensure product complaints are investigated and resolved, in accordance with internal requirements and regulatory expectations. - Support product compliant reconciliation with the call center and Pharmacovigilance. - Continuously improve the internal product complaint program in accordance with applicable laws and regulations. - Serve as Auditor for internal audits and external audits. - Ensure internal and external audit responses and appropriate CAPAs are identified and managed through to resolution in a timely manner and deliverables are met. - Continuously improve internal and external audit programs to remain current with applicable laws and regulations. - Provide support for the initial review, periodic review, and revision of Summit QTAs. - Write, revise, review and/or approve SOPs and other controlled documents. - Ensure issues are identified and managed through resolution in a timely manner, management is notified, and deliverables are met. - Participate in developing, reporting, reviewing and trending of quality and performance metrics, including in support of Annual Product Reviews (APRs). - Support GMP inspection readiness activities. - All other duties as assigned. Experience, Education and Specialized Knowledge and Skills: - Bachelor’s degree in chemistry, biochemistry, biotechnology, or other related life science discipline. - Minimum of 5+ years of relevant experience. - Experience managing product complaints. - Strong knowledge of FDA, EMA, MHRA, ICH, PIC/S and international GMP/ GDP regulations governing clinical and commercial biologics. - Experience serving as an auditor in both internal and external audits. - Experience reviewing and approving QTAs. - Demonstrated ability working within an eQMS to manage and close quality records in accordance with established timelines. - Experience working with CMOs. - Excellent communication skills both oral and written. - Ability to work in a fast paced environment and efficiently manage projects and timelines. - Experience working individually and within a team while balancing priorities. - Attention to detail, accuracy, and thoroughness expected in all aspects of work. - Self-motivated with a strong sense of work ethic. This is the pay for this position Pay Transparency $139,000—$163,000 USD 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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. ## About Summit Therapeutics ## Company Overview - **One-liner**: Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on discovering, developing, and commercializing novel bispecific antibody therapies, with its lead candidate ivonescimab targeting PD-1 and VEGF for multiple solid tumors. - **Entity Type**: Public (NASDAQ: SMMT) - **Headquarters**: Miami, Florida, USA (with additional offices in Palo Alto, CA; Princeton, NJ; Oxford, UK; and Dublin, Ireland) - **Founded**: 2003 - **Founders**: Not publicly disclosed on the company website; the company was founded in 2003. ## Core Business - **Primary industry**: Biopharmaceuticals / Oncology - **Target customers**: B2B (healthcare providers, patients, and caregivers) with a focus on resolving serious unmet medical needs in oncology - **Mission statement**: "To resolve serious, unmet medical needs for the betterment of overall human health." [smmttx.com](https://smmttx.com/company/about-us/default.aspx) ## Products & Services - **Ivonescimab (SMT112)**: A novel, potential first-in-class investigational bispecific antibody targeting both PD-1 and VEGF. It is designed to combine immunotherapy (PD-1 blockade) with anti-angiogenesis (VEGF blockade) into a single molecule. Currently being studied in several global Phase 3 clinical trials for non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and head and neck squamous cell carcinoma (HNSCC). Licensed from Akeso, Inc. (HKEX: 9926.HK) for territories including the U.S., Canada, Europe, Japan, Latin America, the Middle East, and Africa. [smmttx.com](https://smmttx.com/pipeline/default.aspx) ## Market Standing - **Valuation/Market Cap**: Approximately $2.7 billion (as of recent data) [linkedin.com](https://www.linkedin.com/company/summit-therapeutics) - **Key Metric**: Annual revenue of approximately $705,000 (reported). The company is pre-commercialization and heavily investing in R&D. Total funding raised since IPO (2015) is not disclosed, but the company has a strong cash position from equity offerings. - **Notable Investors/Partners**: Akeso, Inc. (key licensing partner for ivonescimab). The company is publicly traded with institutional and retail investors. - **Growth Signals**: - Headcount grew 72.5% year-over-year to 244 employees. [linkedin.com](https://www.linkedin.com/company/summit-therapeutics) - Multiple global Phase 3 trials actively recruiting (HARMONi, HARMONi-3, HARMONi-7, HARMONi-GI3, ILLUMINE). - Over 4,000 patients have been treated with ivonescimab across all clinical trials globally. [smmttx.com](https://smmttx.com/pipeline/default.aspx) - Achieved Great Place to Work® Certification. [smmttx.com](https://smmttx.com/careers/careers-overview/default.aspx) ## Competitive Advantages - **Novel Mechanism**: Ivonescimab is a first-in-class bispecific antibody targeting both PD-1 and VEGF simultaneously, potentially offering superior efficacy and fewer side effects compared to combination therapies. - **Speed and Execution**: The company emphasizes "high-speed execution in commercialization" and has rapidly initiated multiple Phase 3 trials. - **Global Reach**: Licensed territories cover major markets (U.S., Canada, Europe, Japan, Latin America, Middle East, Africa) with a strong partner (Akeso) in the rest of the world. - **Strong Balance Sheet**: With a $2.7B market cap and public listing, the company has access to capital markets to fund its pipeline. ## Strategic Focus - **Current priorities**: Advancing ivonescimab through Phase 3 clinical trials across multiple solid tumor indications (NSCLC, CRC, HNSCC), with the goal of regulatory approval and commercialization. - **Future direction**: Expanding the pipeline into additional solid tumors and leveraging the bispecific platform for future therapies. The company is focused on becoming a leading oncology player. - **Near-term milestones**: Data readouts from ongoing Phase 3 trials, potential regulatory submissions, and building commercial infrastructure. ## Why Work Here - **Culture**: The company has achieved Great Place to Work® Certification, indicating a positive, supportive, and fulfilling work environment. Core values include Commitment to People, Integrity, Passion for Excellence, Purposeful Urgency, Accountability, and Collaboration. [smmttx.com](https://smmttx.com/careers/careers-overview/default.aspx) - **Work Environment**: Fast-paced, high-energy atmosphere focused on innovation and collaboration. The company emphasizes "making a significant difference in patients’ lives." - **Benefits (U.S.)**: - 401(k) with 6% employer match - Employee Stock Purchase Plan (ESPP) with 15% discount up to the annual federal limit - Flexible Spending Account - Commuter Benefit - Onsite lunch provided - **Benefits (U.K.)**: - Private Medical Insurance - Employee Assistance Program - Life Assurance Policy - Company Pension Contributions - ESPP - **Remote/Hybrid Policy**: Not explicitly stated, but multiple office locations suggest a hybrid or on-site presence is expected for many roles. - **Open Roles**: 25 active job postings (as of recent data) including Senior Director of Sales Operations, Clinical Scientists, Medical Science Liaisons, and Drug Product MSAT roles. [greenhouse.io](https://job-boards.greenhouse.io/summitherrapeutics) - **Headcount Growth**: 72.5% year-over-year growth signals a scaling organization with opportunities for career advancement. ## Sources 1. [smmttx.com - About Us](https://smmttx.com/company/about-us/default.aspx) 2. [smmttx.com - Investor Relations Overview](https://www.smmttx.com/overview/default.aspx) 3. [smmttx.com - Pipeline](https://smmttx.com/pipeline/default.aspx) 4. [smmttx.com - Careers Overview](https://smmttx.com/careers/careers-overview/default.aspx) 5. [linkedin.com - Summit Therapeutics Company Page](https://www.linkedin.com/company/summit-therapeutics) 6. [greenhouse.io - Summit Therapeutics Careers](https://job-boards.greenhouse.io/summitherrapeutics) ## Other roles at Summit Therapeutics - [Executive Oncology Account Manager (Asheville)](https://feeny.ai/job/executive-oncology-account-manager-asheville-summit-therapeutics-asheville-xea3xrskjcqw) — Asheville, NC - [Executive Oncology Account Manager (Portland)](https://feeny.ai/job/executive-oncology-account-manager-portland-summit-therapeutics-portland-0cjhm9gw84jh) — Portland, OR - [Executive Oncology Account Manager (Memphis)](https://feeny.ai/job/executive-oncology-account-manager-memphis-summit-therapeutics-memphis-n4vbnmrsdwqb) — Memphis, TN - [Executive Oncology Account Manager (Des Moines)](https://feeny.ai/job/executive-oncology-account-manager-des-moines-summit-therapeutics-des-moines-a8wf1x3paf3y) — Des Moines, IA - [Executive Oncology Account Manager (Knoxville)](https://feeny.ai/job/executive-oncology-account-manager-knoxville-summit-therapeutics-knoxville-g3gr9z1f730s) — Knoxville, TN - [Associate Director, CMC / Quality Project Management](https://feeny.ai/job/associate-director-cmc-quality-project-management-summit-therapeutics-princeton-0bc35yd129z5) — Princeton, NJ - [Senior Clinical Trial Manager](https://feeny.ai/job/senior-clinical-trial-manager-summit-therapeutics-remote-6zvca64c4wcr) - [Executive Oncology Account Manager (Fort Worth)](https://feeny.ai/job/executive-oncology-account-manager-fort-worth-summit-therapeutics-fort-worth-q76xdp78qxqz) — Fort Worth, TX - [Executive Oncology Account Manager (Cincinnati)](https://feeny.ai/job/executive-oncology-account-manager-cincinnati-summit-therapeutics-cincinnati-yr41k1s11h9s) — Cincinnati, OH - [Executive Oncology Account Manager (Worcester)](https://feeny.ai/job/executive-oncology-account-manager-worcester-summit-therapeutics-worcester-ggnt93btghw6) — Worcester, MA