[Remote] Clinical Operations Quality Manager

Note: The job is a remote job and is open to candidates in USA. Hologic, Inc. is a leading company in breast and skeletal health technologies, and they are seeking a Clinical Operations Quality Manager to oversee and execute clinical trials. This role involves ensuring quality oversight and compliance in clinical studies while collaborating with cross-functional teams and external partners.ResponsibilitiesLead the planning, execution, and oversight of clinical studies from start-up through close-out, ensuring trials are conducted according to established quality standards, protocols, and regulatory requirementsEnsure adherence to Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory standards for clinical trialsCritically review study-related documentation, including protocols, informed consent forms, site instructions, study manuals, eCRFs, data review plans, IRB submissions, IDE applications, and other trial documentationIn collaboration with the Clinical team, select and manage CROs and other external vendors/consultants, including:Contract and budget negotiationOversight of CRO activities from award through trial closeoutOversee quality assurance and monitoring activities related to clinical trialsContribute to the creation, review, and maintenance of Standard Operating Procedures (SOPs) governing clinical operations activitiesParticipate in the preparation of regulatory filings and support interactions with regulatory bodies, as neededDevelop and implement processes and tools to improve the efficiency and effectiveness of clinical operations from a quality perspectiveImplement and maintain quality assurance processes, including audits, monitoring, and quality control checksIdentify, manage, and resolve deviations from established quality standards and procedures; initiate and support CAPA as requiredPrepare reports on quality metrics and maintain accurate, timely documentation of quality-related activities in the Quality Management System (QMS)Perform other function-related duties as required by business needsSkillsBachelor's Degree required with 8+ years of relevant experience; orMaster's Degree with 6+ years of experience; orPhD with 3+ years of experienceExperience running clinical trials and working for a sponsor or CRO in the medical device industryExperience developing and managing academic–industry partnershipsProven experience in the management of quality processes within clinical operationsStrong track record in managing complex clinical studies and trials, ideally in medical devicesIn-depth understanding of quality processes and regulatory requirements in the medical device space, including GCP and ICH guidelinesDemonstrated ability to conduct audits and quality checks, and to initiate and manage CAPA when requiredExcellent oral and written communication skills, including strong presentation skills and the ability to effectively represent and communicate the company's position to internal and external stakeholdersProven interpersonal skills and success in a matrixed, cross-functional environmentStrong organizational skills with the ability to multi-task, manage multiple projects, and adapt to changing prioritiesStrategic thinker with the ability to set and manage priorities and allocate resources effectivelyCollaborative, team-oriented mindset with a focus on achieving shared goalsClinical or research experience in breast cancer screening, diagnostics, and/or treatment domains strongly preferredBenefitsCompetitive salaryAnnual bonus schemeComprehensive trainingContinued development and training throughout your careerCompany OverviewWe’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. It was founded in 1985, and is headquartered in Marlborough, Massachusetts, USA, with a workforce of 5001-10000 employees. Its website is http://www.hologic.com.Company H1B SponsorshipHologic, Inc. has a track record of offering H1B sponsorships, with 3 in 2026, 31 in 2025, 20 in 2024, 15 in 2023, 32 in 2022, 20 in 2021, 14 in 2020. Please note that this does not guarantee sponsorship for this specific role.