Provides quality oversight of QC laboratory activities, ensuring compliance with global GxP regulations across multiple indications.
Manages GMP testing at CMOs and contract testing laboratories, including raw data review and exceptions management.
Collaborates with CMC Manufacturing, Quality Assurance, and Regulatory Affairs to align testing timelines with corporate goals.
Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. They are a publicly traded, clinical-stage biopharmaceutical company with a dynamic, fast-paced, entrepreneurial culture.
Provide quality oversight of sterile drug product and finished drug product manufacturing, labeling, packaging, and distribution operations.
Review and approve batch production records, process validation documents, and quality system records such as deviations and change controls.
Support regulatory agency inspections and author NDA CMC sections to ensure compliance with GMP and GDP standards.
Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs, such as post-bariatric hypoglycemia, Wolfram syndrome, and ALS. The company has an experienced team driven by core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of caring.
Oversee sterilization processes within medical devices and provide technical support across all certification schemes as a fully remote role.
Lead a team of MDR Product Assessors-Sterilization, manage resource planning, and drive team performance against global targets.
Develop and maintain sterilization QMS documentation aligned with best practices and applicable regulatory requirements.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability, quality, and integrity. With 99,600 employees operating a network of 2,600 offices and laboratories, we offer a dynamic, international work environment with a focus on professional development and sustainability.
Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.
Lead operational oversight of clinical external manufacturing for drug product, transitioning monoclonal antibodies into scalable processes.
Develop robust aseptic strategies for vial and prefilled syringe formats, managing CMOs and technology transfers.
Collaborate with formulation and device teams to create stable high-concentration liquid formulations and troubleshoot manufacturing issues.
We develop potentially best-in-class therapies for patients with severe autoimmune diseases. Our lead antibody, claseprubart, is engineered for extended half-life and improved potency, and we are building a culture centered on core principles to elevate patient care.
Act as subject matter expert for the Document Control process area, owning lifecycle management of quality processes and records.
Serve as System Administrator of Veeva’s internal electronic Document Management System (eDMS), responsible for configuration and continuous improvement.
Provide quality oversight on regulated activities, such as process definition, validation testing, and product releases for in-scope systems.
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.
Own the operational foundation enabling the Product organization to scale effectively.
Administer product tooling (Aha!, Amplitude, Jira, Maze) and ensure data quality across teams.
Partner with compliance to support FDA design controls and maintain repeatable regulatory workflows.
Lingraphica is a mission-driven organization providing speech-generating devices to improve communication for people with aphasia and other impairments. They are a leader in AAC technology, operating in a fast-paced, goal-oriented environment with a focus on helping individuals and families.
Own first-line triage of bug reports and operational issues, reproducing and validating before escalation.
Build and run a product enablement program for operations, ensuring features are adopted and understood.
Instrument the intake system, categorize feedback, and deliver recurring reports to feed roadmap planning.
Splitero helps homeowners access home equity without monthly payments, addressing a gap left by traditional lenders. As a remote-first team with a culture of transparency and inclusivity, we offer comprehensive benefits and flexible PTO.
Responsible for site activation readiness, including preparation and submission of Clinical Trial Application Forms to Competent Authorities and Ethics Committees.
Manage collection of essential documents, customize informed consent forms, and coordinate translations for study-specific documents.
Maintain communication with key functions (Feasibility, Clinical Operations, Regulatory) and update project trackers and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization focused on precision medicine, combining novel clinical trial designs and advanced biomarker solutions, particularly in rare diseases and oncology. The company is growing and seeks dedicated professionals to support its mission, fostering a culture where employees feel appreciated and their ideas valued.
Provide scientific leadership for QC GMP activities, including method transfer and lifecycle management for drug substance and drug product.
Lead investigations of deviations, OOS, and OOT results, and implement CAPAs.
Collaborate with cross-functional teams and external partners to ensure compliant QC operations.
Cogent Biosciences is a publicly traded biotechnology company developing novel precision therapies for rare diseases and cancer. With a collaborative culture and offices in Waltham, MA and Boulder, CO, they focus on advancing their pipeline through clinical trials.
Manage TMF operations activities for multiple complex studies or sponsor portfolios.
Oversee Trial Master File quality control including planning, tracking, and reporting.
Support regulatory inspections and sponsor audits while collaborating with cross-functional teams.
This is a global clinical research environment focused on ensuring accuracy, compliance, and quality of essential trial documentation. The company operates with a collaborative international team and values inclusion, professional growth, and purpose-driven healthcare work.
Lead TMF activities for clinical trials across start-up, maintenance, close-out, and archive phases.
Oversee eTMF health, quality issue workflows, and compliance with regulatory standards.
Support TMF document processing, audits, and continuous improvement initiatives.
Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases such as MASH. They are part of Novo Nordisk and foster a collaborative culture with diverse skill sets.
Implement and maintain best-in-class quality systems in compliance with FDA, ICH, 21 CFR Part 11, and ISO 9001.
Foster a culture of quality excellence and continuous improvement across the organization.
Manage day-to-day activities of a lean, high-performing quality team and optimize workflows.
N-Power Medicine aims to reinvent drug development by transforming clinical trials through better integration with clinical practice. They are building a multi-disciplinary team with diverse expertise in healthcare, engineering, technology, and regulatory, sharing a core value of empowering community through generosity, curiosity, and humility.
Lead all operational and lifecycle management aspects of Regulatory CMC submissions supporting cell therapy development programs.
Develop and execute global regulatory CMC strategies aligned with program objectives and regulatory requirements.
Serve as Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.
Manage day-to-day regulatory affairs support, including clinical trial applications and compliance with global regulations.
Provide expert guidance to project stakeholders, ensuring timely and high-quality service delivery.
Develop regulatory strategies and tools, staying current with industry best practices and regulatory changes.
Alimentiv provides global regulatory affairs support services for clinical research. The company emphasizes high-quality service delivery, compliance with industry standards, and a collaborative culture.
Provide sponsor oversight of CMO QC labs and maintain control strategies for investigational cell therapy products.
Manage validation of analytical methods and stability programs to support clinical trials.
Investigate laboratory deviations and ensure risks are managed to resolution.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. Guided by core values of innovation and collaboration, they are a growing company committed to transforming treatment for autoimmune disease.
Build, maintain, and continuously improve the company's Quality Management System (QMS) and oversee GxP CSV requirements.
Own the design and administration of the electronic QMS, including validation, document control, and compliance activities.
Lead internal audit and inspection-readiness programs, supporting regulatory inspections and promoting a culture of quality.
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs, targeting the underlying drivers of aging to delay disease and preserve quality of life. As a well-funded startup with teams of scientists, veterinarians, engineers, and creatives, it is pioneering the first FDA-approved lifespan extension medicine.
Execute regulatory strategies for obtaining registration approval of Intuitive's medical device portfolio in APAC indirect markets.
Coordinate with Distributor RAs and internal stakeholders to compile regulatory documentation and ensure compliance with medical device regulations.
Manage regulatory submission tracking in systems like Veeva and perform periodic surveillance activities using TrackWise.
Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to advancing minimally invasive care. The company has built an inclusive and diverse team of great people for over 25 years, grounded in integrity and a strong capacity to learn.
Lead execution of RBQM strategy across complex clinical trials, including risk assessments and monitoring plans.
Partner with cross-functional teams and CROs to identify, track, and mitigate risks proactively.
Ensure compliance with global regulations, drive process improvements, and report KRIs to leadership.
Deciphera is a biopharmaceutical company focused on developing kinase inhibitor therapies for cancer. The company offers a competitive compensation package and promotes a culture of personal and professional growth.