Senior Manager, CMC Quality Operations

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…

Join Alector as the Senior Director of CMC Technical Operations, where you will lead innovative efforts in the development of siRNA therapeutics. This pivotal role involves overseeing the entire lifecycle of CMC activities, ensuring regulatory compliance, and driving the strategic direction of our product pipeline. Your expertise will be instrumental in collaborating with cross-functional teams to advance our mission of harnessing the power of RNA therapeutics.

About Us: Calico Life Sciences LLC is a pioneering research and development company established by Alphabet, dedicated to uncovering the biological mechanisms of human aging. Our vision is to leverage cutting-edge technologies and innovative model systems to deepen our understanding of aging biology and to develop interventions that promote longer, healthier lives. With state-of-the-art technology labs and a commitment to curiosity-driven scientific discovery, we collaborate with academic and industry leaders to drive a vibrant drug-development pipeline, making Calico an inspiring environment for realizing medical breakthroughs. Role Overview: As the Director of Regulatory CMC, you will spearhead the formulation and execution of global regulatory strategies for our portfolio of small molecules and monoclonal antibodies. This pivotal role will enhance clinical development timelines and facilitate smooth commercialization processes. Collaborating closely with CMC and Quality teams, you will oversee the CMC components of all investigational and marketing applications, ensuring technical coherence and regulatory compliance throughout the product lifecycle, from development to market launch. The successful candidate will possess profound scientific knowledge, exceptional attention to detail, and adept negotiation skills with global health authorities, particularly regarding the specific regulatory pathways for small molecules and monoclonal antibodies. Key Responsibilities: Regulatory Strategy and Interaction with Authorities: Develop and execute innovative global CMC regulatory strategies to obtain approvals and maintain compliance for clinical and commercial products, identifying risks and devising effective mitigation strategies. Provide expert guidance on CMC requirements for both small molecules and biologics, including comparability protocols and stability assessments. Serve as the primary CMC liaison for the FDA, EMA, and other international regulatory bodies. Lead preparation efforts and represent the company in formal regulatory meetings, including responding to inquiries from Health Authorities. Evaluate the impacts of manufacturing changes on global registrations and determine reporting requirements worldwide. Define necessary data packages to support post-approval submissions. Submissions and Document Leadership: Oversee the preparation and technical review of CMC sections for global submissions.

Lead and strategize all CMC regulatory initiatives to ensure adherence to global regulatory standards for the development of ORIC's innovative products.Deliver CMC regulatory support for both new and ongoing clinical trials, including the management and preparation of CMC documentation for INDs, CTAs, and amendments submitted to global regulatory agencies (RAs) and health authorities (HAs).Collaborate effectively with teams in Pharmaceutical Development, Drug Substance, GMP Quality Assurance, Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.Oversee the preparation and responses for CMC-related meetings with global RAs and HAs, aligning regulatory obligations with corporate goals.Stay updated with global CMC regulations and proactively identify and assess regulatory risks, formulating mitigation strategies.Plan, supervise, and manage all CMC components of regulatory submissions, including strategies for updating existing dossiers and submitting new INDs, CTAs, NDAs, MAAs, and more.Assess proposed manufacturing modifications for their global impact on existing filings and provide strategic regulatory guidance for effective implementation.Offer hands-on assistance in generating CMC documentation (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).

Join Oric Pharmaceuticals as the Director of CMC Development for Rinzimetostat, where you will lead a dynamic team focused on advancing our innovative therapies. In this pivotal role, you will oversee the development and manufacturing processes, ensuring the successful delivery of our products from concept to market.

AbbVie Inc. is hiring a Senior Manager, Clinical Quality Assurance in South San Francisco. This position plays a key part in shaping and executing quality assurance strategies for clinical trials. The focus is on upholding regulatory compliance and supporting the delivery of safe, effective therapies. Role overview This role oversees the development and rollout of quality assurance plans within clinical research. The Senior Manager works closely with cross-functional teams, guiding them to maintain high quality standards at every stage of clinical development. What you will do Develop and implement quality assurance strategies for clinical trials Ensure all clinical activities meet regulatory requirements Advise and support teams to achieve consistent quality across projects Requirements Experience in clinical quality assurance Strong understanding of regulatory standards for clinical trials Ability to lead and guide cross-functional teams

Join our dynamic team at 360 IT Professionals as a Senior Project Manager specializing in Quality Management Systems. In this role, you will lead critical projects, ensuring the highest standards of quality and compliance are met. Your expertise will drive continuous improvement initiatives and facilitate effective communication across teams.

Join Alumis Inc., a pioneering precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Despite substantial advancements in treatment over the past two decades, many individuals with immunologic conditions continue to face challenges. Our mission is to fundamentally improve outcomes for these patients.The Senior Manager of Pharmacovigilance (PV) Safety Operations will report to the Director of PV Safety Operations. This pivotal position is essential for ensuring the timely reporting, processing, and submission of Individual Case Safety Reports (ICSRs) originating from ongoing clinical trials and post-marketing studies. The role encompasses oversight of case processing vendors, management of the ICSR process, collaboration with cross-functional teams during study execution, and support for inspection readiness activities, all while ensuring strict compliance with regulatory requirements.

Join AbbVie as a Senior Scientist I in our Quality Control team focused on Biologics Analytical Research & Development. In this pivotal role, you will leverage your expertise in analytical methods to ensure the quality and compliance of our biologic products. Collaborate with cross-functional teams to drive innovative solutions and contribute to the advancement of our research initiatives.

At Bee Genius, we are pioneering the workplace of tomorrow, today.This position is being advertised on behalf of our client:We are in search of a seasoned Director of Quality and Regulatory Affairs to become a pivotal part of our team. In this role, you will be tasked with ensuring that our quality standards and regulatory compliance are upheld for a renowned pharmaceutical organization based in South San Francisco. You will spearhead a talented team responsible for the development and implementation of robust quality management systems and processes that ensure our products meet excellence and comply with regulatory demands.

About ZiplineZipline is the leading global provider of drone delivery services, dedicated to ensuring equitable access to essential goods such as food, medicine, and supplies, whenever and wherever they are needed. We operate the largest autonomous logistics system in the world, executing deliveries with remarkable speed and reliability. Currently, Zipline's services span four continents, achieving a new delivery every 30 seconds, and we have successfully completed millions of deliveries, including critical items like blood, vaccines, and medical supplies.Our clientele comprises the most prominent healthcare systems, governments, and businesses worldwide, all of whom depend on us to save lives, minimize emissions, and enhance economic opportunities through rapid and efficient logistics solutions. Our innovative approach to supply chain management enhances efficiency and reduces congestion, allowing people to reclaim valuable time.We are on a mission to redefine access to healthcare and consumer products globally, having flown over 140 million commercial autonomous miles safely. We seek practical problem solvers who thrive in dynamic environments and are passionate about creating impactful solutions in logistics.About You and The Role As a Senior Logistics Operator at Zipline, you will take charge of outbound logistics operations at our South San Francisco facility. Your primary responsibility will be to ensure the efficient distribution and fulfillment of finished goods and spare parts, supporting both commercial deployments and testing operations.You will play a pivotal role in Zipline's physical supply chain, overseeing daily outbound logistics while enhancing the systems and processes that facilitate scalability. You should be adept at navigating uncertainty, anticipating downstream impacts, and driving results with minimal supervision.Your responsibilities will encompass managing outbound distribution performance metrics, including on-time shipment, fulfillment accuracy, lead times, and cost efficiency to guarantee high-quality outcomes for both internal teams and external customers.

Role Overview Cellares is seeking a Senior Operational Technology Engineer in South San Francisco, CA. This role focuses on strengthening and improving operational technology systems across the company. What You Will Do Work closely with teams from different departments to improve operational systems. Apply technical knowledge to boost the efficiency and reliability of technology supporting operations. Help identify and implement solutions that improve overall performance and support operational goals.

We are seeking an innovative and strategic Operations Manager for Special Projects to join our dynamic team at Stripe. This exciting role involves overseeing a variety of special projects that drive operational excellence and promote the growth of our services. You will collaborate with cross-functional teams to identify opportunities for improvement, streamline processes, and implement effective solutions.The ideal candidate will possess exceptional leadership skills, a strong analytical mindset, and a passion for driving results in a fast-paced environment. If you thrive on challenges and have a track record of successful project management, we want to hear from you!

At Alumis Inc., we are at the forefront of precision medicine, dedicated to revolutionizing the lives of individuals suffering from autoimmune diseases. Despite significant advancements in treatment over the past two decades, many patients continue to experience hardships. Our mission is to fundamentally transform patient outcomes through innovative solutions.We are currently in search of a dynamic and results-oriented Senior Director of Trade Operations. This pivotal leader will be responsible for the vision, design, and execution of U.S. trade and distribution strategies specifically for our dermatology and immunology product lines. This position is essential in establishing efficient and scalable pathways that enhance product accessibility for patients and healthcare providers.Reporting directly to the Senior Vice President of Market Access, the successful candidate will join a dedicated commercialization team focused on impactful results. Ideal applicants will possess a strategic mindset, thrive in fast-paced environments, and have a demonstrated ability to develop and implement strategies while being deeply engaged in the execution process.

At Alumis Inc., we are dedicated to revolutionizing the treatment of autoimmune diseases through precision medicine. Despite advancements in treatment over the past two decades, many patients with immunologic conditions still endure significant challenges. Our mission is to fundamentally improve the health outcomes for these individuals.We are on the lookout for a proficient Senior Manager, FP&A – Research & Technical Operations to join our dynamic team in a rapidly expanding environment. This pivotal role will act as a strategic finance business partner to our Research and Technical Operations divisions, aiding in a diverse portfolio of programs and operational initiatives. You will be essential in steering the planning and forecasting processes, providing crucial decision support to functional leadership, and assisting the Sr. Director of FP&A in the overall planning strategy and execution. This position also requires close collaboration with the Accounting team during month-end close processes.

About Zipline Zipline operates the world’s largest autonomous drone delivery network, providing essential goods such as food and medicine to people wherever they live. With operations on four continents and a delivery completed every 30 seconds, Zipline has completed millions of successful shipments, including blood, vaccines, medical supplies, food, and retail items. Clients include major healthcare systems, governments, retailers, and global organizations that rely on Zipline to deliver critical resources quickly and reliably. The company’s logistics platform helps optimize supply chains, reduce congestion, and support communities worldwide. With over 140 million commercial miles flown autonomously, Zipline is changing how healthcare, consumer goods, and food reach those who need them most. Zipline’s team values practical problem solving, adaptability, and a drive to build systems that make a real difference. The company is growing rapidly and seeks people who think creatively, welcome challenges, and can deliver results at scale. Role Overview: Program Manager, Talent Acquisition Operations The Program Manager, Talent Acquisition Operations will play a key part in building and improving the systems that power Zipline’s hiring. This is a high-impact, cross-functional individual contributor position suited for someone who thrives in ambiguity and can move between strategy and hands-on execution. This role involves not just refining recruiting processes, but also designing and defining them. Success depends on close collaboration with Recruiting, People, Finance, and leadership teams to help shape a data-driven hiring engine.

About ZiplineAre you ready to make a difference? At Zipline, we harness the power of drones to deliver essential and life-saving medicines to hospitals around the globe, impacting millions of lives. Our mission is to ensure that every individual on Earth has immediate access to crucial medical supplies. Join us at Zipline and be part of a transformative journey that can reach billions.About the RoleAs a Quality Manufacturing Engineer within our manufacturing quality team, you will play a pivotal role in ensuring that each vehicle produced meets Zipline’s stringent performance criteria. Your responsibilities will include managing inspection findings and non-conformances, leading investigations into root causes, and implementing corrective measures to enhance yield and production efficiency. You will outline and document inspection protocols, rework procedures, and provide feedback to suppliers, collaborating with cross-functional teams to address quality issues effectively.

About ZiplineZipline is the foremost leader in autonomous delivery services, dedicated to providing equitable access to essential goods for all individuals, anytime and anywhere. We have engineered the world's largest autonomous logistics system, ensuring prompt and reliable delivery of vital supplies. Operating on four continents, Zipline makes a delivery every 30 seconds and has successfully completed millions of deliveries, including blood, vaccines, medical supplies, food, and commercial products. Our clientele encompasses healthcare systems, governmental bodies, retailers, and global brands that depend on us to save lives, minimize emissions, enhance economic opportunities, and deliver scalable logistics services.Our technology surpasses conventional drones, as we deploy integrated logistics infrastructure designed to fortify supply chains, alleviate congestion, and facilitate instant deliveries, revolutionizing how essential goods reach communities worldwide. With over 140 million commercial autonomous miles flown safely, Zipline is transforming access to healthcare, consumer products, and food globally.We operate at a global scale and seek practical problem solvers who thrive on real-world challenges and rapid growth. Our team is driven by the mission to create systems that have a direct and significant impact on people's lives while shaping the future of logistics.About You and The RoleWe are in search of a highly motivated operator to establish the sales infrastructure and enablement foundation for Zipline’s SMB restaurant partnerships.This role will collaborate closely with sales leadership and field sellers to develop processes, tools, and playbooks that empower Zipline to consistently sign, launch, and support local restaurant partners across various markets.This is a hands-on, builder role; you will define the current SMB motion while laying the groundwork for its national scalability.This position is based at our headquarters in South San Francisco, CA.Your ResponsibilitiesDevelop the SMB sales playbook Strategize and document the outreach motion, messaging, and sales process for securing local restaurant partners, enabling successful approaches to be replicated across new markets.Establish core sales infrastructure Design CRM workflows, pipeline stages, dashboards, and reporting to provide leadership with clear visibility into sales activities, conversion rates, and market performance.

Zipline is looking for a Technical Program Manager to focus on ground systems and operations at its South San Francisco, California location. This role centers on guiding the planning, deployment, and ongoing performance of new ground systems. Key Responsibilities Lead the deployment process for new ground systems, managing each phase from initial planning through launch. Oversee both construction and ongoing service operations related to these systems. Coordinate closely with engineering, operations, and other teams to ensure projects meet schedule and quality standards. Identify and drive operational improvements to sustain strong ground system performance. Collaboration This position works with a variety of teams to coordinate project execution and maintain high standards in service operations.

We are seeking a dedicated Operations Manager to lead our operational strategies and enhance productivity at Artech Information Systems LLC. In this role, you will oversee daily operations, implement efficient processes, and ensure excellence in service delivery. Your leadership will be crucial in driving team performance and achieving organizational goals.