Job Title: QMS Senior Specialist Job Description The Senior Manager, Quality Systems, will manage the electronic Quality Management System (eQMS) and assist end users in ensuring compliant document management, training, and quality system execution, including change control, quality events, and CAPA. We looking for someone to assist with the administration of the ZenQMS system they have in place. This person will be responsible for supporting end users to ensure compliant document management, training, and quality system execution (including change control, quality events, and CAPA). Responsibilities + Assign training, administer eQMS user access, and provide end user support in ZenQMS. + Support document management activities in the electronic QMS, including the creation, revision, and periodic review of documents. + Support compliant execution of Quality Systems records, such as change controls, quality events, and CAPAs, and perform associated Quality approvals. + Assist in Quality Management System development and enhancement, covering training, change management, quality event management, supplier qualification, and audit. + Generate metrics and report on the compliance status of systems/processes, including document management, quality events, corrective actions, and change management. + Facilitate weekly CMC quality system records review. + Establish and facilitate the Change Review Board. + Promote a company-wide culture of quality. Essential Skills + Expertise in quality management systems and auditing. + Experience in optimizing quality systems and process mapping. + Proficiency in using tools like SharePoint. + Ability to manage and implement quality systems effectively. Additional Skills & Qualifications + Bachelor’s degree in a science-related field. + Eight years of relevant Quality experience in the biotech industry, preferably with gene or cell therapy experience in an early-phase organization. + Strong understanding of GxP Quality and expertise in Quality Management System development and execution. + Experience managing Quality Systems for external manufacturing. + Knowledge of Biologics manufacturing sciences and processes at clinical and commercial stages. + Experience engaging with global health authorities. + Ability to work in a fast-paced clinical-phase environment. + Strong collaboration, team-building, and organizational skills. Work Environment This is a remote position, offering the opportunity to work in a close-knit team that collaborates across different departments, playing an instrumental role in the success of the organization. Pay and Benefits The pay range for this position is $80.00 - $90.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Aug 26, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.