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Experience Level
Senior Level Manager
Qualifications
Key Responsibilities:Manage both internal and external quality operations to support GMP manufacturing activities for clinical and commercial purposes. Plan, organize, and lead all QA Operations activities including material release, batch record review, QC testing, lot disposition, Quality Event Management, and Annual Product Report reconciliation. Act as the Quality Lead on program teams, including product development and manufacturing operations. Lead Quality Event Management, CAPA, and change control processes effectively. Facilitate cross-functional teams in risk analysis related to CAPA, Change Controls, complaint investigations, failure investigations (FMEA), and hazard assessments (HACCP). Utilize expert knowledge in root cause analysis to guide team efforts. Mentor and develop the Quality Operations team, fostering a collaborative culture that enhances quality outcomes and operational excellence. Collaborate cross-functionally to ensure preparedness for pre-approval inspections and commercial readiness activities. Arbitrate compliance discussions and negotiate necessary corrective actions. Identify and implement enhancements to Quality Operations processes.
About the job
The Director of Quality Operations oversees global GMP quality at Eyepoint Pharmaceuticals, supporting both internal and external manufacturing. This position plays a key role in development and commercial programs, ensuring quality standards are consistently met across all operations. Reporting to the Senior Director of Global Quality Assurance, the Director leads both the Quality Operations and Quality Engineering teams. Daily responsibilities include providing direct support for quality-related activities and guiding team efforts to maintain compliance and operational excellence.
Location and schedule
This role is based at the Northbridge, MA facility. The company offers a hybrid work arrangement, requiring at least three days per week on-site. During major project milestones, on-site presence may be needed more frequently. The position also involves regular travel to the Watertown location, typically one to two times per week. Occasional travel to external partner sites is expected, accounting for approximately 5-10% of the time.
About Eyepoint Pharmaceuticals
At Eyepoint Pharmaceuticals, we are dedicated to advancing the field of ophthalmology through innovative therapeutic solutions. Our team is committed to quality, and we strive to maintain the highest standards in all our operations. Join us in our mission to improve patient outcomes and drive success in the pharmaceutical industry.
Full-time|On-site|Middleton, Wisconsin, United States
About UsJoin a dynamic and rapidly expanding technology organization that empowers our clients with unparalleled access to geospatial imagery and data solutions. At Cyclomedia, we leverage state-of-the-art technology to capture, analyze, and visualize spatial data, transforming how organizations utilize geographical information.Position OverviewWe are on the…
The Quality Operations Manager plays a pivotal role in facilitating the transition from outdated paper-based processes to a robust and compliant Electronic Quality Management System (eQMS). This position is essential for ensuring that the Quality System effectively supports all phases of drug development, including nonclinical and clinical development, regulatory submissions (IND, NDA/BLA), commercialization, and product lifecycle management.The Quality Operations Manager is tasked with maintaining compliance with relevant GxP requirements (GLP, GCP, GMP), FDA regulations, global standards, and industry best practices. This role also emphasizes readiness for inspections, regulatory submissions, vendor oversight, and the promotion of a quality-centric culture throughout the organization.Key Responsibilities:eQMS Transition:Evaluate current paper-based procedures and devise a comprehensive plan for transitioning to electronic workflows.Ensure data integrity, compliance with Part 11 where necessary, and proper system validation.Facilitate the integration of GxP processes across all functional areas into a cohesive, risk-based framework.Quality System Management:Develop, implement, and uphold procedures for document control, training management, handling deviations and nonconformances, CAPA, change control, risk management, audit management, and complaint handling (if applicable).Coordinate and deliver training on GxP procedures.Support for External Quality Operations: If applicable.Inspection Readiness & Regulatory Interface:Lead inspection readiness initiatives across the organization.Manage regulatory agency inspections (e.g., FDA, EMA, and other global authorities).Oversee the timely and effective development and implementation of CAPAs in response to regulatory findings.Cross-Functional Leadership:Collaborate with Clinical, Regulatory, CMC, Nonclinical, IT, and Commercial teams.Provide training and foster a culture of quality across the organization.Act as a quality advisor to senior leadership.
Full-time|Remote|Seattle, New York City, Boston, or Remote
As the Manager of Quality Operations at Pearl Health, you will play a crucial role in ensuring the highest quality of our health services. You will lead a dedicated team to develop and implement effective quality control processes, ensuring compliance with industry standards and enhancing patient care. Your analytical skills and attention to detail will be key in driving our quality initiatives and improving operational efficiency.
Full-time|$152.3K/yr - $192.1K/yr|On-site|Alameda, California, United States
THE COMPANYSaildrone is a pioneering maritime defense organization and the foremost authority in autonomous unmanned surface vehicles (USVs). With unparalleled experience traversing ocean miles and real-world operations, Saildrone actively supports national security and force projection globally, 24/7/365.Our manufacturing and R&D headquarters are situated in Alameda, CA, complemented by business development and sales operations in Washington, DC, and deployment hubs across Europe and the Middle East. By integrating proven autonomous operations, edge computing, advanced sensing, renewable energy, and cutting-edge unmanned surface technology, Saildrone is redefining the operational capabilities of future naval forces. Come be a part of a dynamic, mission-driven team at the forefront of maritime security and autonomous innovation.THE POSITIONWe are looking for a Senior Operations Quality Manager to enhance our Operations Team. Reporting directly to the Chief Operating Officer, you will spearhead the daily execution and evolution of our Quality Management System, ensuring that every vehicle delivered meets the highest standards of reliability, traceability, and performance. As production scales and product complexity increases, you will guarantee that our quality systems advance in tandem with the business—from supplier qualifications through manufacturing, deployment, and fleet operations. We seek a hands-on technical leader adept at creating clarity from ambiguity, driving disciplined follow-through, and possessing a proven history of successful execution in fast-paced hardware environments.THE TEAMThe Operations Team oversees the manufacturing, deployment, and maintenance of Saildrone’s autonomous surface vehicles. We develop and uphold the operational infrastructure necessary to ensure global maritime domain awareness within a national security and defense framework. Quality is central to this mission—connecting manufacturing and field service to swiftly identify issues, thoroughly resolve root causes, and close feedback loops efficiently. This role collaborates across Engineering, Supply Chain, Production, and Technical Operations to maintain rigor as we scale.THE RESPONSIBILITIESMature and expand the Quality Management System (QMS) to achieve ISO9001 and/or AS9100D compliance, overseeing internal/external audits, documentation controls, and traceability systems to meet stringent certification criteria.Establish and manage company-wide quality KPIs (e.g., First Pass Yield, defect rate, cost of quality) and reporting dashboards to provide...
As an Operational Development Specialist III - Quality Manager at StemXpert, you will play a pivotal role in ensuring the highest standards of quality across our operational processes. Your expertise will guide the development and implementation of quality management systems, fostering a culture of continuous improvement. You will collaborate with cross-functional teams to analyze operational performance, identify areas for enhancement, and drive initiatives that align with our strategic goals.
About GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a pioneering global biotechnology enterprise established in 2002. With a strong international footprint across North America, Europe, Greater China, and the Asia Pacific region, GenScript specializes in cutting-edge gene synthesis technology, providing services in Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is dedicated to its mission of becoming the most trusted biotech company globally, enhancing health for both humanity and nature through the advancements of biotechnology.Job ScopeThe Senior Manager of Quality Operations will oversee the Manufacturing and Quality Control Shop-Floor Quality, Batch Release, Document Control, and Training functions. This role is pivotal in managing quality functions aligned with Good Manufacturing Practices (GMP) and ensuring Phase-Appropriate compliance for clinical and marketed Gene Therapy products and Plasmid DNA at our Hopewell manufacturing facility. The candidate will be expected to foster and develop the team in line with the company's growth objectives.Essential Responsibilities:Lead the Probio Quality Operations and Batch Release Program for Gene Therapy and Plasmid Manufacturing. Responsibilities may include, but are not limited to:Developing procedures and executing local batch disposition for Gene Therapy Drug Substance, Drug Product, Master Cell Bank (MCB), Plasmid, and Finished Goods produced at the Hopewell, NJ site.Issuing batch compliance documentation including Certificates of Conformance/Compliance/Quality (CoCs/COQs), Certificates of Analysis (CoAs), and BSE/TSE Statements.
The future of AI — whether in training or evaluation, classical ML or agentic workflows — hinges on the availability of superior data.At HumanSignal, we are pioneering the platform that fuels the creation, curation, and evaluation of high-quality data. Our tools facilitate everything from fine-tuning foundational models to validating agent behaviors in production, empowering leading AI teams to ensure models are anchored in real-world signals rather than noise.Our open-source product, Label Studio, has emerged as the de facto standard for labeling and evaluating data across various modalities — encompassing text, images, time series, and agents in environments. With over 250,000 users and hundreds of millions of labeled samples, it stands as the most widely adopted OSS solution for teams dedicated to building AI systems.Label Studio Enterprise builds on this momentum by incorporating the security, collaboration, and scalability features essential for supporting mission-critical AI pipelines — from model training datasets to evaluation test sets and continuous feedback loops. As we advance in an era where AI is reshaping industries, we are excited to invite candidates who are eager to assist premier AI teams in constructing smarter and more accurate systems.We are looking for a Quality Operations Lead to uphold exceptional data quality across our Label Studio platform and Data Creation Laboratory operations. In this pivotal role, you will serve as the ultimate authority on the integrity and utility of the data we create and deliver to our clients. You will lead accountability across our most impactful projects, addressing complex quality challenges while spearheading strategic initiatives that ensure reliable and scalable delivery as we expand.Our Data Creation Laboratories go beyond labeling existing data; we engineer purpose-built datasets from the ground up in controlled settings. This elevates the quality control process: you won’t just be verifying annotations; you will ensure that the human-generated data we produce meets the rigorous standards demanded by cutting-edge AI laboratories and enterprises pushing the boundaries of innovation.
Join Resillion as a Quality Control Operator where you will play a vital role in ensuring our products meet the highest standards of quality. You will be responsible for conducting inspections and tests, documenting results, and collaborating with production teams to implement improvements. This position offers an exciting opportunity for those passionate about quality assurance in a dynamic environment.
Join DoorDash as an Associate Manager in our Quality Assurance Strategy & Operations team, where your expertise will help shape our quality initiatives and enhance operational efficiency. You will collaborate with cross-functional teams to develop and implement QA strategies that align with our business objectives.
Full-time|$123.6K/yr - $151.8K/yr|On-site|New York, New York
ABOUT THE ROLE The Manager of Quality Improvement for 3PL Operations will spearhead initiatives aimed at enhancing quality across the North American Final Mile network. This pivotal role involves collaborating closely with stakeholders in quality engineering, warranty management, training, and member support to prioritize and implement quality improvement strategies. The ideal candidate will possess deep expertise in Final Mile Procedures and will serve as the representative for the Final Mile Operations team in all quality-related efforts. This position requires proficiency in analyzing large datasets to identify root causes, establish clear strategic objectives, and facilitate cross-functional collaboration to enhance the member experience during installation. Key responsibilities include driving down installation issues and improving the member experience during delivery. The Manager will liaise with both internal and external teams to ensure that all quality-related procedures and information are accessible and presented in a user-friendly format for our 3PL installation teams. YOUR DAILY IMPACT AT PELOTON Implement a data-driven quality improvement strategy aimed at enhancing first-time installation success, while reducing warranty claims, field failures, swaps, and return rates. Oversee timelines, risks, and issues pertaining to quality improvement projects, ensuring proactive communication and resolution.
Join WelbeHealth as the Director of Quality Operations, where you will lead initiatives to enhance the quality and efficiency of our healthcare services. In this pivotal role, you will be responsible for developing and implementing quality improvement strategies that align with our mission to provide exceptional care to our patients.
City Wide Facility Solutions – AustinJoin Our Team as a Night Manager – Operations & Quality ExecutionAbout UsAt City Wide Facility Solutions in Austin, we are dedicated to enhancing environments that uplift our clients, contractors, and team members. We are proactive operators, committed to quick problem-solving and ownership in our work. Our competitive spirit drives us to succeed and exceed expectations.Your RoleAs the Night Manager, you will play a crucial role in ensuring the highest service quality across our portfolio during nighttime operations. This is an active position that requires hands-on problem-solving responsibilities including:Stabilizing client accountsEnsuring consistent execution of servicesSupporting Field Service Managers (FSMs) by proactively resolving issues before they impact clientsYou will be the operational eyes and ears after hours, driving quality and performance.Work ScheduleThis is a full-time position from Monday to Friday, 5:30 PM to 2:00 AM, with flexibility for emergencies and occasional weekend work.Success MetricsIdentifying and resolving issues before clients are awareEnsuring contractors are accountable and continuously improvingEquipping FSMs with solutions to start their days positivelyDelivering services that consistently meet or exceed standardsKey Responsibilities1. Proactive Quality ExecutionConduct nightly inspections across priority accountsAddress and rectify issues in real-time rather than just reporting themEnsure consistent execution of the scope of work2. Contractor Management & AccountabilityTrain and hold Independent Contractors (ICs) accountable to established standardsImmediately address performance issues and escalate when necessaryEnsure adequate staffing and resources for each account3. FSM Support & CommunicationProvide concise nightly summaries of actions taken, beyond mere observationsIdentify risks early and suggest effective solutionsCollaborate with FSMs to enhance account stability4. New Starts & Problem AccountsManage new account launches to create strong first impressionsAssist in revitalizing troubled accounts with focused attentionDeliver exceptional service where necessary5. Supply & Operational StandardsEnsure proper usage of chemicals, tools, and equipmentIdentify and communicate supply needs proactivelyReinforce City Wide standards across all accountsPhysical RequirementsFrequent walking, standing, and bendingCapability to lift up to 30 lbsTraveling between multiple client locations during night shifts
Full-time|$193.6K/yr - $244.5K/yr|Hybrid|Northbridge, MA
Role overview The Director of Quality Operations oversees global GMP quality at Eyepoint Pharmaceuticals, supporting both internal and external manufacturing. This position plays a key role in development and commercial programs, ensuring quality standards are consistently met across all operations. Reporting to the Senior Director of Global Quality Assurance, the Director leads both the Quality Operations and Quality Engineering teams. Daily responsibilities include providing direct support for quality-related activities and guiding team efforts to maintain compliance and operational excellence. Location and schedule This role is based at the Northbridge, MA facility. The company offers a hybrid work arrangement, requiring at least three days per week on-site. During major project milestones, on-site presence may be needed more frequently. The position also involves regular travel to the Watertown location, typically one to two times per week. Occasional travel to external partner sites is expected, accounting for approximately 5-10% of the time.
Full-time|$174K/yr - $227K/yr|On-site|South San Francisco, California, United States
About Us Kardigan is a pioneering company dedicated to transforming heart health by making cardiovascular diseases preventable and curable, striving to eliminate it as the leading cause of death globally.Our mission is to develop multiple targeted therapies in parallel, ensuring that individuals suffering from cardiovascular diseases have access to the cures they deserve. Founded by renowned experts Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan is backed by a legacy of success from their work at MyoKardia, where they played pivotal roles in the discovery and development of mavacamten, the first cardiac myosin inhibitor, which led to its acquisition by Bristol Myers Squibb in 2020. We boast an advanced discovery and translational research platform, a robust pipeline of late-stage candidates, and an exceptional team committed to enhancing patient lives. At Kardigan, our values shape our interactions and drive our success. We are patient-focused, prioritizing the needs of patients and their families. Our commitment to authenticity fosters an inclusive environment where everyone is valued. With an eagerness to learn, we encourage curiosity and adaptability. We believe in team success, striving for excellence, and supporting each other in our roles. Finally, we aim to enable the impossible, embracing risks to spur innovation and advance scientific breakthroughs. These guiding principles empower us to make a tangible difference every day.
About xAIAt xAI, we are dedicated to developing artificial intelligence systems that truly understand the universe and support humanity's quest for knowledge. Our team is compact, driven, and committed to engineering excellence. We welcome individuals who challenge themselves and thrive on curiosity. Our flat organizational structure encourages hands-on contributions to our mission. We reward initiative and excellence, with a strong emphasis on work ethic and prioritization. Effective communication is essential; all team members are expected to share knowledge concisely and accurately with their peers.ABOUT THE ROLE:The Program Manager for Quality & Training will spearhead the strategy, development, and implementation of quality and training programs within Safety Operations. This role is pivotal in creating scalable systems designed to enhance moderator performance, foster critical thinking, and improve decision-making accuracy.Reporting to the Manager of Safety Operations & Enablement, you will supervise two Safety Trainers and manage the entire lifecycle of training and quality initiatives—ranging from program design and forecasting to delivery, measurement, and ongoing improvement. This high-visibility role has a direct impact on operational excellence, content integrity, and product trust.RESPONSIBILITIES:Craft and implement a comprehensive, automation-first quality and training strategy that aligns with Safety Operations and product goals.Integrate AI tools and enhance workflows within learning and quality processes.Establish scalable onboarding and continuous learning frameworks to accommodate workforce expansion.Ensure training and quality initiatives align with hiring scales, operational changes, and performance metrics.Design and fine-tune training programs that cover policy interpretation, critical thinking, AI tool usage, and moderation accuracy.Develop facilitator guides, educational materials, assessments, and reinforcement strategies.
About Waymo Waymo began as the Google Self-Driving Car Project in 2009 and has since become a leader in autonomous driving technology. The company’s mission centers on developing the Waymo Driver, technology designed to improve mobility and reduce traffic-related fatalities. Waymo’s fully autonomous ride-hailing service operates across multiple vehicle platforms and use cases. To date, Waymo vehicles have provided over ten million autonomous rides and logged more than 100 million miles on public roads in 15+ U.S. states. Team Overview: Software Quality Operations (SWQOps) The Software Quality Operations team ensures the safety, reliability, and quality of the Waymo Driver. This group builds and refines an adaptable operational framework, increasingly supported by AI, to deliver the insights needed for Waymo’s growth and service improvements. Why SWQOps Matters at Waymo Waymo is expanding into about 20 new cities by the end of 2026. As the company grows, SWQOps plays a central role in supporting safe and efficient scaling. The Scenario Operations team within SWQOps manages simulation-based testing coverage, which is essential for evaluating the safety and performance of the Waymo Driver as operations expand. De-risking New Deployments: The team analyzes both real and simulated driving events, identifies issues, and monitors field operations. This proactive approach delivers early warnings and insights, supporting operational resilience and safety as Waymo enters new cities and enhances platforms such as Ojai. Supporting Engineering Progress: SWQOps handles performance evaluations, in-depth issue analysis, and data set management. This allows Engineering, Systems Engineering, Simulation, and Data Science teams to focus on advancing the Waymo Driver. Enabling Market Expansion: SWQOps contributes to every stage of Waymo’s market entry process, from initial city assessments to scaling operations. The team provides data analysis, policy development, and quality assurance to help clear critical milestones for successful launches.
About BelongAt Belong, we envision a future where homes are accessible to everyday individuals rather than corporations. Our mission is to foster authentic belonging experiences, empowering residents to transition into homeowners and helping existing homeowners achieve financial independence. We are constructing a scalable wealth creation system through homeownership, having navigated the challenges of Covid, the tech downturn, and the most demanding periods in capital markets. Our team of over 200 Belongers is dynamic, inquisitive, and driven by ambition.The RoleBelong is on the lookout for a passionate operations leader to spearhead a pivotal mission: ensuring a seamless inspection, onboarding, tour, and move-in experience for every home and resident across the nation. This role demands a commitment to operational excellence, an appreciation for six sigma precision, and a belief in the power of systems driven by discipline, mathematics, and AI to shape and enhance our reality.Key ResponsibilitiesDesign and implement an AI-driven system that underpins Belong's inspections and onboarding nationwide, leveraging our proprietary software to create a flawless, infinitely scalable process.Execute onboarding repairs adhering to six sigma standards, overseeing every detail from the initial inspection to the final touches.Manage QA inspections and post-QA repairs, proactively eliminating defects before they impact residents.Ensure an impeccable move-in experience for every resident at Belong, without exception.Coordinate Open Home tours nationwide, delivering precision, reliability, and consistency at one of our most impactful touchpoints.Build, scale, and motivate a world-class team focused on discipline, precision, and quality.What We SeekTop-tier MBA or Master's degree in Operations from a renowned institution in the U.S., demonstrating your capacity to operate at the highest levels.Military training in an officer role (IDF, US Army) is highly advantageous.Exceptional analytical and operational skills: someone who not only manages complexity but thrives within it.Unwavering discipline and a strong work ethic. We need a leader who consistently outworks and outthinks others, being the first in and last out of the office.Commitment to cultural diversity: We are a global team that values leaders with diverse perspectives.A passion for operations, finding fulfillment in every aspect of the process.
Waymo, the leader in autonomous driving technology, is seeking a dedicated Software Quality Operations Specialist to join our innovative team. This role involves ensuring the highest quality standards in our software products. As a key player in our quality assurance processes, you will collaborate closely with engineering and product teams to implement effective testing strategies, identify issues, and enhance our software solutions.
Join Mindlance as a Digital Acquisitions Quality Control and Operations Project Manager, where you will play a pivotal role in ensuring our digital acquisition processes are seamless and efficient. You will oversee quality control measures, streamline operations, and collaborate cross-functionally to enhance our digital strategy.Your expertise in project management and quality assurance will be vital in driving initiatives that foster innovation and excellence within our team. We are looking for a proactive leader who thrives in a dynamic environment and is passionate about digital transformation.
Full-time|$140.8K/yr - $176K/yr|On-site|Waltham, MA
Zenas BioPharma is a pioneering biopharmaceutical company at the forefront of developing and commercializing transformative therapies for patients suffering from autoimmune diseases. Our strategic approach combines a seasoned leadership team with a rigorous process for acquiring and developing innovative product candidates globally. We are focused on delivering superior clinical benefits to patients affected by autoimmune disorders. We are advancing two late-stage flagship molecules: obexelimab and orelabrutinib. Obexelimab is our lead candidate, a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, aimed at inhibiting the activity of pathogenic B cells without causing depletion. This innovative therapy offers a self-administered subcutaneous injection regimen, addressing chronic autoimmune diseases effectively. Orelabrutinib, on the other hand, is a highly selective oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). We also have promising earlier-stage programs, including a preclinical oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor.We are on the lookout for exceptional talent who share our dedication to improving patient outcomes and possess a proven track record in global product acquisition, development, and commercialization. Joining Zenas provides an opportunity to thrive in a dynamic learning environment where individual and organizational success is paramount as we aspire to become a global leader in immunology and autoimmune disease management. Our core values—Transparency, Relationships, Urgency, Excellence, and Innovation—drive us toward TRUE Innovation!Position Summary:As the Senior Manager of Global Quality Assurance for Technical Operations, you will report directly to the Director of Global Quality Assurance for Medical Devices and Combination Products. This strategic role encompasses hands-on quality oversight for late clinical-stage and commercial manufacturing activities at Zenas BioPharma’s Contract Manufacturing Organizations (CMOs). You will ensure the highest standards of GMP compliance across our global operations, facilitate regulatory submissions and inspections, and drive continuous improvement initiatives alongside internal teams and external manufacturing partners. Your responsibilities will include overseeing batch manufacturing and testing, process validation, and ensuring inspection readiness to maintain robust product quality throughout the development lifecycle.
