GondolaBio Service Co, Inc. - Director, Quality Assurance

GondolaBio Service Co, Inc. - Director, Quality Assurance





















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Director, Quality Assurance






GondolaBio Service Co, Inc.





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Director, Quality Assurance




Fully Remote









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Description
Company BackgroundGondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. Originally carved out of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.Portal Therapeutics is an early clinical stage biotechnology company, and the lead program in GondolaBio’s portfolio. Portal is developing a novel potential best-in-class therapy for erythropoietic protoporphyria, a severe genetic disease of the blood which results in extreme sensitivity to sunlight and liver damage.To learn more, visit us at gondolabio.comWho You AreThe Director of Quality Assurance (QA) will lead the development and execution of quality strategies supporting clinical-stage and/or commercial products. This role ensures compliance with global GxP regulations while operating in a fast-paced, innovation-driven setting. The Director will continue to build scalable quality systems, support regulatory submissions, and provide QA oversight across clinical development, manufacturing, and external partnerships.
Requirements
1. Quality Systems & Build-OutContinue to build, implement, and scale a phase-appropriate Quality Management System (QMS)Establish SOPs, quality policies, and training frameworks for a growing organization.Ensure inspection readiness at all times.2. Clinical & Development QAProvide QA oversight for GCP and GLP activities supporting clinical trialsReview clinical protocols, investigator brochures, and study reportsSupport IND, BLA, or MAA submissions with quality input3. CMC & Manufacturing Oversight (Initial Focus of Role)Oversee GMP compliance for products in development.Provide QA support for tech transfer, process development, and scale-up.Ensure proper review and disposition of batch records, deviations, and investigations.4. External Partner & Vendor QualityManage QA oversight of CDMOs, CROs, and suppliers across all functions.Lead vendor qualification, audits, and quality agreementsMonitor partner performance and compliance5. Regulatory Inspections & AuditsEnsure readiness and hosting of FDA, EMA, and global regulatory inspectionsManage internal audits and mock inspectionsDrive CAPA development and effectiveness checks6. Risk-Based Quality & InnovationApply ICH Q9 risk management principles in decision-makingImplement agile, scalable QA processes suited for company’s growth stagesLeverage digital tools and data analytics for quality insights7. Leadership & CultureWork and partner with a high-performing QA teamPromote a “quality by design” mindset across the organizationPartner cross-functionally with R&D, Clinical, Regulatory, and Technical Operations Education, Experience, & Skills Requirements EducationBachelor’s degree in Life Sciences (Biology, Biochemistry, Molecular Biology, etc.)Advanced degree (MS, PhD) preferredExperience10–15 years in QA within biotech or biopharmaStrong experience in clinical-stage development and manufacturingProven leadership in a startup or high-growth biotech environment preferredCore CompetenciesExpertise in GMP, GCP, GLP regulations and complianceStrong experience with regulatory submissions (IND, BLA, MAA)Ability to build systems from the ground up and scale with growthExcellent leadership, communication, and cross-functional collaboration Preferred SkillsFamiliarity with digital QMS tools (e.g., Veeva)Experience preparing for pre-approval inspections (PAI) What We OfferPatient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts.A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.An unyielding commitment to always putting patients first.A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science.A place where you own the vision – both for your program and your own career path.A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game.Access to learning and development resources to help you get in the best professional shape of your life.Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs).Flexible PTORapid career advancement for strong performers.Partnerships with leading institutions.Commitment to Diversity, Equity & Inclusion.The base pay range for this position is $220,000 to $250,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.


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