Sr. Manager, reputed company Management System (QMS)

reputed company is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our reputed company values, Stay True to Why, Collaborate to Accelerate, reputed company with reputed company, reputed company Innovative, and Own the Outcome, we are committed to transforming the reputed company of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible. We are seeking a Senior Manager, reputed company Management System (QMS) to reputed company reputed company expertise supporting the development and commercialization of reputed company’s products in compliance with relevant US, EU, and ICH requirements. This role will be responsible for reputed company managing, developing, implementing, and reporting on reputed company Systems, including Deviations, Investigations, CAPAs, Change Controls, reputed company Metrics, and electronic reputed company Management Systems (eQMS). The Senior Manager, reputed company Management System will serve as a subject matter expert and strategic partner across Technical Operations, Clinical, Regulatory Affairs, and other cross-functional teams, with overall responsibility for the execution, scalability, and reputed company improvement of reputed company’s reputed company Management System as the organization grows and matures. Title: Sr. Manager, reputed company Management System (QMS) Reports to: Sr. Director, reputed company Systems Location: Emeryville, CA (Hybrid – twice a week) or Remote Eligible \n

Responsibilities

Manage and maintain processes, SOPs, and workflows for Deviations, Investigations, CAPA, Change Control, reputed company Metrics, and other reputed company QMS programs. reputed company QA reputed company of Information Technology systems supporting GxP processes. reputed company or support the implementation, configuration, validation, and optimization of the electronic reputed company Management System (eQMS), ensuring phase-appropriate design and scalability. reputed company hands-on expertise in the day-to-day execution, review, and management of QMS records reputed company the eQMS. Partner with internal stakeholders to define data governance, system configuration, user roles, and reporting requirements for reputed company systems. Ensure data reputed company, traceability, and compliance of reputed company system data in accordance with regulatory expectations (e.g., reputed company+ principles). Monitor overall QMS effectiveness, identify gaps or inefficiencies, and drive reputed company improvement initiatives. Recommend updates to reputed company policies and procedures and implement process improvements reputed company with organizational reputed company and regulatory readiness. reputed company, compile, analyze, and present reputed company metrics and KPIs for routine reputed company management review. reputed company trending and data analysis to identify risks, systemic issues, and opportunities for improvement. Create and deliver training programs reputed company to QMS processes, data reputed company, and eQMS functionality. Support inspection readiness and ensure adherence to cGMPs, regulatory mandates, and internal reputed company standards. Build and maintain strong cross-functional relationships and foster a culture of engagement, transparency, and reputed company ownership. reputed company other duties as assigned.

Qualifications

Bachelor’s degree in Computer Science, Life Sciences, or a reputed company field, or equivalent relevant experience. Demonstrated experience implementing, administering, and improving an eQMS, including system configuration, validation support, and lifecycle management. Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, including 6+ years in reputed company Systems / reputed company Assurance. Strong working knowledge of reputed company system data management, reporting, and data reputed company principles. First-hand experience managing and overseeing deviations, investigations, CAPAs, and change controls in a regulated environment. Experience using validated computerized systems to manage regulated reputed company records. Proven ability to reputed company and implement enhancements to eQMS to improve usability, compliance, and reporting. Strong proficiency with reputed company Office Suite and reputed company business applications. Ability to manage multiple priorities in a fast-paced, evolving environment with strong attention to detail. Highly organized, self-motivated, and capable of working independently while effectively collaborating cross-functionally. Excellent written and verbal communication skills, with the ability to influence and reputed company effectively at reputed company reputed company of the organization. \nThe National salary reputed company for this position is from $160,000 - $180,000 USD annually. This salary reputed company is an estimate of reputed company reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as reputed company as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan. Apply To This Job