{"id":2932071,"url":"https://alion.io/job/smmttx-manager-quality-assurance","title":"Manager, Quality Assurance","company":{"id":21096,"name":"Smmttx","domain":"smmttx.com","url":"https://alion.io/company/smmttx","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":75,"open_postings":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-24T06:02:35Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Princeton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":139000,"max":163000,"currency":"USD","period":"year","gross":null,"usd_annual":163000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-20T13:03:45Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-24T21:42:49Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"About Summit:\nSummit 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.\nSummit’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:\nNon-small Cell Lung Cancer (NSCLC)\nHARMONi: 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.\n\nHARMONi-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.\n\nHARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.\n\nColorectal Cancer (CRC)\nHARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.\n\nIvonescimab 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.\nOverview of Role: \nThe 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). \nRole and Responsibilities: \nServe as the liaison for our commercial product complaint call center and also manage clinical product complaints. \nEnsure product complaints are investigated and resolved, in accordance with internal requirements and regulatory expectations. \nSupport product compliant reconciliation with the call center and Pharmacovigilance. \nContinuously improve the internal product complaint program in accordance with applicable laws and regulations. \nServe as Auditor for internal audits and external audits. \nEnsure internal and external audit responses and appropriate CAPAs are identified and managed through to resolution in a timely manner and deliverables are met. \nContinuously improve internal and external audit programs to remain current with applicable laws and regulations. \nProvide support for the initial review, periodic review, and revision of Summit QTAs. \nWrite, revise, review and/or approve SOPs and other controlled documents. \nEnsure issues are identified and managed through resolution in a timely manner, management is notified, and deliverables are met. \nParticipate in developing, reporting, reviewing and trending of quality and performance metrics, including in support of Annual Product Reviews (APRs). \nSupport GMP inspection readiness activities. \nAll other duties as assigned. \nExperience, Education and Specialized Knowledge and Skills: \nBachelor’s degree in chemistry, biochemistry, biotechnology, or other related life science discipline. \nMinimum of 5+ years of relevant experience. \nExperience managing product complaints. \nStrong knowledge of FDA, EMA, MHRA, ICH, PIC/S and international GMP/ GDP regulations governing clinical and commercial biologics. \nExperience serving as an auditor in both internal and external audits. \nExperience reviewing and approving QTAs. \nDemonstrated ability working within an eQMS to manage and close quality records in accordance with established timelines. \nExperience working with CMOs. \nExcellent communication skills both oral and written. \nAbility to work in a fast paced environment and efficiently manage projects and timelines. \nExperience working individually and within a team while balancing priorities. \nAttention to detail, accuracy, and thoroughness expected in all aspects of work. \nSelf-motivated with a strong sense of work ethic. \nThis is the pay for this position\nPay Transparency\n$139,000—$163,000 USD\nActual 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.\nSummit 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  to obtain prior written authorization before referring any candidates to Summit.\nSummit 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.","description_format":"text","description_chars":6042,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-20T14:54:10Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":3,"expected_fill_days":35,"reasons":["conf:4","win:early"],"computed_at":"2026-10-24T06:02:35Z"},"pay":{"stated_usd_annual":163000,"is_top_pay":true},"html_url":"https://alion.io/job/smmttx-manager-quality-assurance","json_url":"https://alion.io/job/smmttx-manager-quality-assurance.json","meta":{"generated_at":"2026-10-25T00:03:17Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":105,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":21096},"rest":"https://alion.io/mcp/rest/get_company?id=21096"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsmmttx-manager-quality-assurance"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fsmmttx-manager-quality-assurance"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fsmmttx-manager-quality-assurance"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/smmttx-manager-quality-assurance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsmmttx-manager-quality-assurance"}]}