--- title: 'Sr Manager, Quality Systems & Compliance at Iambic Therapeutics, Inc' canonical: 'https://feeny.ai/job/sr-manager-quality-systems-compliance-iambic-therapeutics-inc-united-states-vsh166q5vj7e' type: 'job' last_seen: '2026-09-09' --- # Sr Manager, Quality Systems & Compliance at Iambic Therapeutics, Inc - **Company:** Iambic Therapeutics, Inc - **Location:** United States - **Employment:** full-time - **Work type:** remote - **Posted:** 2026-08-31 - **Last confirmed live:** 2026-09-09 - **Apply:** https://jobs.ashbyhq.com/iambic-therapeutics/cd83cc34-0ac3-411d-b0da-8f37a67d4841 ## Job description ## JOB SUMMARY This role will assist in leading activities within Quality Systems and Compliance, with responsibility for designing and implementing a Quality Management System (QMS) that supports current clinical development programs and the organization’s growing pipeline. Quality Systems & Compliance partners closely with Regulatory, Medical, Clinical, R&D, and Technology leadership to ensure quality systems enable innovation, maintain compliance, and support continuous inspection readiness across U.S. and global clinical programs. This position can be remote based in the US or hybrid based in our San Diego headquarters. ## KEY RESPONSIBILITIES - Execute and support ongoing effectiveness of the Quality Management System (QMS). - Work closely with Quality management to manage deviations and investigations, CAPA, change controls, risk assessments, quality events, and effectiveness checks internally and while working with external partners and suppliers/vendors - Create controlled documents and governance frameworks covering core processes from establishment throughout continuous improvement efforts - Support regulatory compliance within drug production activities - Execute a quality roadmap that translates regulatory and quality requirements into practical, scalable operating models aligned with current compliance needs and future organizational growth - Proactively identify and mitigate compliance risk through data-driven monitoring - Foster a culture of accountability, transparency, and quality ownership across the organization - Provide quality oversight and coordination for internal and third-party audits - Prepare the organization for inspection readiness for U.S.-based and global clinical programs through established quality systems, governance, and cross-functional alignment. ## QUALIFICATIONS - Bachelor’s degree in a scientific or technical field, such as biology, chemistry, engineering, or related health science, with 6+ years of progressive Quality experience within a GxP-regulated industry - Experience supporting inspection readiness, audits, or regulatory interactions through quality systems and cross-functional collaboration - Experience managing, implementing or improving a Quality Management System - Experience with implementing and maintaining electronic quality management systems (eQMS) such as Veeva, ZenQMS, MasterControl, etc. - Familiarity with global regulatory expectations applicable to clinical development, including U.S. and international considerations. - Working knowledge of GCP and applicable GMP principles as they relate to quality systems - Strong understanding of risk-based quality systems and continuous improvement concepts - Experience partnering and leading cross-functional teams, including Regulatory, CMC, Clinical Operations, Information Technology and R&D - Strong technical writing, organizational, and problem-solving skills. - Demonstrated ability to translate regulatory and quality requirements into practical, scalable processes ## ABOUT IAMBIC THERAPEUTICS Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai http://iambic.ai. ## MISSION & CORE VALUES Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies. ## PAY AND BENEFITS We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play. ## About Iambic Therapeutics, Inc ## Company Overview - **One-liner**: Iambic Therapeutics is a clinical‑stage biotechnology company that uses an AI‑driven platform to discover and develop novel small‑molecule medicines for oncology and other diseases. - **Entity Type**: Private (late‑stage venture‑backed) - **Headquarters**: San Diego, California, United States - **Founded**: 2020 - **Founders**: Not explicitly named in available sources; leadership includes a Co‑Founder & CEO and a Co‑Founder & CTO. ## Core Business - **Primary industries**: Biotechnology, AI‑powered drug discovery, oncology therapeutics - **Target customers**: B2B partnerships with pharmaceutical companies (e.g., Bayer) and, ultimately, patients through a wholly‑owned pipeline of clinical‑stage candidates - **Mission**: *“Better technology for better medicines”* – using machine learning and automation to transform the creation of new therapeutics ## Products & Services - **Enchant Platform**: A multi‑modal transformer AI that breaks down data barriers between preclinical and clinical R&D, enabling rapid molecular design. - **NeuralPLexer**: A co‑folding AI technology that predicts protein‑ligand structures to guide drug design. - **Automated High‑Throughput Experimentation**: AI‑driven robotics that generate new biological data from novel molecular designs on a weekly cadence. - **IAM1363** (HER2 inhibitor): A highly selective, brain‑penetrant tyrosine kinase inhibitor for HER2‑driven cancers; currently in Phase 1b clinical studies. - **IAM‑C1** (CDK2/4 dual inhibitor): A potential first‑in‑class selective inhibitor for HR+/HER2‑ metastatic breast cancer (preclinical). - **IAM‑K1** (KIF18A inhibitor): A potential best‑in‑class allosteric inhibitor for triple‑negative breast cancer, ovarian cancer, and other solid tumors (preclinical). - **Undisclosed programs**: Additional wholly‑owned candidates across multiple target classes and mechanisms. ## Market Standing - **Valuation**: Not publicly disclosed - **Key Metric**: **Total funding** – $330.8 M (including a $100 M Series B in Oct 2023, a $50 M Series B extension in Apr 2024 led by EXOR N.V. and Mubadala Capital, and a $127.8 M venture round in Nov 2025) - **Notable Investors/Partners**: EXOR N.V., Mubadala Capital, Nexus Venture, Bayer (collaboration in AI drug discovery), and a Scientific Advisory Board including Nobel Laureate Frances Arnold (Caltech) - **Growth Signals**: - Headcount of **117** (64.5 % year‑over‑year growth) - Active job postings: **18** (+200 % quarterly, +50 % yearly) - Pipeline advanced from program launch to IND in **2 years** (vs. 6‑year industry average for IAM1363) - Broad platform applicability demonstrated across orthosteric, allosteric, and protein‑protein interaction modalities ## Competitive Advantages - **Speed**: AI‑driven platform can deliver development candidates to clinical trials in roughly one‑third the industry average time. - **Selectivity & Differentiated Profiles**: IAM1363 shows > 5000‑fold selectivity against EGFR, avoiding EGFR‑driven toxicity; IAM‑C1 targets CDK2/4 with a novel selectivity profile. - **Broad Platform Applicability**: Platform has produced leads across diverse protein classes and mechanisms (orthosteric, allosteric, PPI modulators). - **Integration of AI and Drug Hunting**: Tightly integrated team of AI experts and seasoned drug hunters, with a culture of “audacity” that tackles hard chemistry problems. ## Strategic Focus - Advancing the clinical pipeline: IAM1363 Phase 1b, preparing IAM‑C1 and IAM‑K1 for IND‑enabling studies. - Expanding platform partnerships (e.g., Bayer collaboration). - Scaling the organization: actively hiring in ML science, computational chemistry, medicinal chemistry, and clinical operations. - Exploring new therapeutic areas and target classes through the Enchant and NeuralPLexer technologies. ## Why Work Here - **Culture**: Values of **Respect**, **Collaboration**, and **Audacity** – cross‑functional teamwork with resilience and optimism; a flat, high‑trust environment. - **Work Model**: Based in La Jolla/San Diego, CA; the company emphasizes on‑site collaboration for drug‑discovery and lab‑based roles; remote/hybrid policy not explicitly stated. - **Team Growth**: Rapidly scaling (headcount +64 % YoY) with a strong pipeline of open roles in ML, computational chemistry, drug product development, and clinical operations. - **Cutting‑Edge Work**: Opportunity to work at the intersection of frontier AI (large multimodal models, agentic data pipelines) and real‑world drug discovery that reaches patients. - **Leadership & Mentorship**: Advisory board includes Nobel laureate and former NVIDIA AI director; close integration of AI and biology. ## Sources 1. [iambic.ai](https://www.iambic.ai/) – Homepage, platform, and corporate overview 2. [iambic.ai/about](https://www.iambic.ai/about) – Leadership, advisory board, investors 3. [iambic.ai/pipeline](https://www.iambic.ai/pipeline) – Pipeline details (IAM1363, IAM‑C1, IAM‑K1) 4. [iambic.ai/careers](https://www.iambic.ai/careers) – Careers page, values, open positions 5. [linkedin.com/company/iambic-ai](https://www.linkedin.com/company/iambic-ai) – Company stats (headcount 117, $3.4M revenue, $330.8M funding, funding rounds, employee growth) ## Other roles at Iambic Therapeutics, Inc - [Sr Manager, FP&A - Discovery R&D](https://feeny.ai/job/sr-manager-fp-a-discovery-r-d-iambic-therapeutics-inc-san-diego-sznt8xkbx741) — San Diego, CA - [Director/Senior Director, Immunology](https://feeny.ai/job/director-senior-director-immunology-iambic-therapeutics-inc-san-diego-pc8aedpavc67) — San Diego, CA - [Software Engineer — Agentic data pipelines](https://feeny.ai/job/software-engineer-agentic-data-pipelines-iambic-therapeutics-inc-united-states-z1afztyyenvn) — United States - [Principal Medical Writer](https://feeny.ai/job/principal-medical-writer-iambic-therapeutics-inc-united-states-p7p8wv9kdmyd) — United States - [Research Scientist I/II, Bioanalytical Sciences & Assay Development](https://feeny.ai/job/research-scientist-i-ii-bioanalytical-sciences-assay-development-iambic-z1xnw171hxqv) — San Diego, CA - [Machine Learning Scientist – Clinical Prediction](https://feeny.ai/job/machine-learning-scientist-clinical-prediction-iambic-therapeutics-inc-boston-r8b4amskssr5) — Boston, MA - [Machine Learning Scientist — Large Multimodal Models (Post-Training)](https://feeny.ai/job/machine-learning-scientist-large-multimodal-models-post-training-iambic-7rzbhfe24hz9) — United Kingdom - [Machine Learning Scientist — Large Multimodal Models (Post-Training)](https://feeny.ai/job/machine-learning-scientist-large-multimodal-models-post-training-iambic-tq20zrdrpft4) — Boston, MA - [Senior / Executive Director, Analytical Development CMC](https://feeny.ai/job/senior-executive-director-analytical-development-cmc-iambic-therapeutics-inc-xc2n3pav2s88) — United States - [Associate Director / Director, Clinical Pharmacology](https://feeny.ai/job/associate-director-director-clinical-pharmacology-iambic-therapeutics-inc-san-je8hv9zyhrrm) — San Diego, CA