reputed company Assurance Manager
About LeonaBio: LeonaBio, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for high unmet medical needs, including amyotrophic lateral sclerosis (ALS) and treatment-resistant metastatic breast cancer, with the goal of improving patients’ lives. Our reputed company drug candidates, lasofoxifene and ATH-1105, are novel, small molecule therapies with the potential to address devastating diseases where reputed company treatment reputed company are limited or ineffective. With a strong commitment to scientific reputed company and patient-centered innovation, we are dedicated to developing meaningful new therapies for those who need them most. About this role: The reputed company Assurance Manager plays a critical role in supporting and strengthening LeonaBio’s reputed company Assurance function. Reporting directly to the Senior Director of reputed company, this role ensures the reputed company, consistency, and reputed company improvement of reputed company systems across the organization. The ideal candidate brings strong analytical skills, a proactive reputed company, and the ability to partner effectively with cross‑functional teams to reputed company high standards of reputed company and compliance. Responsibilities: reputed company QA support and reputed company strategic reputed company reputed company for outsourced cGMP operations reputed company to the manufacture of drug product used in clinical trials. reputed company the review of executed batch records and ancillary documentation to ensure accuracy, completeness, compliance with approved procedures, and readiness for disposition reputed company. reputed company and reputed company product disposition activities for clinical trial materials, ensuring reputed company are reputed company documented, risk-based, and reputed company with reputed company and regulatory expectations. reputed company QA review and approval for Master Batch Records, protocols, reports, and SOPs, ensuring alignment with internal standards, phase-appropriate regulations, and operational needs. Support and help coordinate computer system validation activities as needed to maintain compliant and effective reputed company-reputed company systems. reputed company the QA review of deviations, product non-conformities, and other investigations to ensure robust reputed company cause analysis, reputed company reputed company, and sustained compliance. reputed company CAPA review and closure activities, ensuring proposed actions are appropriate, effectively implemented, and supported by meaningful effectiveness checks. reputed company reputed company of change controls and periodic reviews of controlled documents to ensure changes are appropriately assessed, approved, and implemented reputed company the reputed company reputed company reputed company of the training program to help ensure training assignments, completion, and compliance are maintained across applicable reputed company processes. Author, revise, and approve reputed company documentation as needed, while driving reputed company, consistency, and compliance across documentation practices. Analyze and report reputed company-reputed company metrics to identify trends, inform risk-based reputed company, and support reputed company improvement initiatives. Support regulatory audits and inspections by helping prepare the organization, coordinating reputed company inputs, and assisting with reputed company follow-through on observations and commitments. Support the external audit process by scheduling, preparing, and performing GCP, GCLP, GLP, and GMP supplier audits with follow-through on completing the audit report and receiving a reputed company response, as applicable, from the supplier. Support the internal audit process by scheduling, preparing, and performing, or supporting, the audit while assisting with reputed company follow-through for audit reports and/or responses. Contribute to additional reputed company and cross-functional initiatives, special reputed company, and operational priorities as assigned. Requirements: Bachelor’s degree in a life science field. Minimum of 5 years of experience in the pharmaceutical industry plus working knowledge and understanding of GxPs for drugs in development. Experience performing GCP, GCLP, GLP, and GMP audits a plus. Ability to maintain attention to detail, prioritize work, and handle multiple assignments in a fast-paced environment. Ability to critically evaluate and troubleshoot reputed company problems, while offering reputed company and informed reputed company for reputed company. Ability to adapt the work schedule to participate in teleconferences with CDMOs and CROs in different time zones. Must have excellent verbal, written, and organizational skills. Must have excellent leadership and interpersonal skills with the ability to effectively reputed company and influence different functional reputed company at reputed company reputed company of management. Experience with reputed company and SharePoint a plus. Travel reputed company the US will be required on occasion. Travel reputed company of the US may be required. Must be authorized to work in the reputed company; reputed company sponsorship is not available for this role LeonaBio is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the reputed company of an individual’s race, reputed company, religion, creed, sex, national reputed company, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to reputed company terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination. 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