Director Quality Operations

22 hours ago

Waltham, United States Mural Oncology Full time

Mural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may meaningfully improve the lives of patients with cancer. By leveraging its core competencies in immune cell modulation and protein engineering, Mural Oncology has developed a portfolio of novel, investigational cytokine therapies designed to address areas of unmet need for patients with a variety of cancers. The Company's lead product candidate, nemvaleukin alfa, is an investigational, engineered interleukin-2 (IL-2) cytokine designed to capture and expand the therapeutic benefits of high-dose recombinant human IL-2, while mitigating its hallmark toxicities.Director, Quality Operations, Development and External QualityDetailed Description: The Quality organization at Mural is dedicated to ensuring compliance and excellence across all research and development activities, encompassing Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GvP), and Good Manufacturing Practice (GMP). This department plays a crucial role in maintaining high standards, supporting regulatory adherence, and fostering a culture of continuous improvement. The Director, Quality Operations, will be a pivotal leader within Mural's Quality organization, responsible for overseeing and managing Quality Operations activities for manufacture of master cell bank, working cell bank, drug substance and drug product/finished goods. This role requires a strategic thinker with deep expertise in CMC/GCP/GMP standards, capable of effectively managing contract manufacturers and ensuring their inspection readiness at all times. The Director will collaborate closely with internal departments and external partners to ensure seamless delivery, supporting Mural's commitment to the highest quality standards.Job Responsibilities:CMC:•Represent Quality on CMC Tech Transfer/DS/DP Sub-Teams as directed. Develop content and present relevant quality topics at the CMC meetings, ensuring pertinent issues/information are shared or escalated to the CMC Leadership team as necessary.•Provide review/comment and approval as applicable for Process Development deliverables including but not limited to process control strategy, process and raw material risk assessments, development studies. •Review and comment on regulatory submissions, including IND, IMPD, MAA, BLA.Quality Operations:•Function as QA Lead for assigned contract manufacturers/Mural programs•Review and approval of Master Batch Records.•Manage/perform lot review/disposition of MCB/WCB/DS/DP/IVSS•Manage/execute resolution of issues including deviations/investigations/supplier change notifications/change requests•Review/approve PPQ Plans, protocols, reports, including CPV.•Coordinate compilation/submission of APQR information from relevant vendors.•Evaluate and continuously improves relevant processes and ways of working. •Develop, maintain, and report performance metrics.•Develop and maintain relationships with department functions internally and collaborate on.Vendor Management Support:•Provides subject matter expert opinion during vendor selection process for Contract Manufacturing Organizations •Provide input to draft Audit Agenda for Qualification, surveillance and For Cause audits for GMP Contract Service Providers.•Assist in management of audit CAPA's to ensure timely completion.•Provide comment to existing/draft quality agreements with all GMP Contract Service Providers to ensure clear expectations and compliance requirements are met.•Provide comment to Mural vendor management documentation including Quality Agreement templates, questionnaires etc.•Ensure application of approved Quality Agreements Supply Chain Quality:•Manage QP relationships.•Manage QP Declaration and Certification activities.•Supports EAP, Clinical and Commercial labelling/packaging operations. •Participates in development/maintenance of risk assessment for each supply chain nodes.•Oversees shipping validation activities for defined shipping lanes.Compliance:•Manage external quality investigations as needed to assess impact and risk, identify root causes, and implement corrective and preventative actions (CAPAs). This includes leading investigations, documenting findings, and ensuring timely and effective resolution of quality issues.•Support Quality Review Board meetings and represent Quality to communicate any trends, issues, or risks related to vendor performance from a quality perspective. This involves preparing and presenting detailed reports and analyses to cross functional teams and senior leadership.Qualifications:•Bachelor's degree in a scientific or related discipline; advanced degree preferred.•A minimum of 12 years of experience in quality management within the pharmaceutical, biotechnology, or related industry. This experience should include GMP Quality operations/QA validation, Quality Systems.•Proven expertise in GCP/GMP regulations and standards, with a deep understanding of how these regulations apply to vendor management and quality assurance.•Thorough understanding and working knowledge of US FDA, and European regulatory requirements, International Conference on Harmonization, and the ability to determine phase appropriate requirements.•Strong experience in quality oversight of external partners.•Demonstrated ability to lead projects and manage multiple vendors effectively.•Excellent leadership, communication, and project management skills. Ability to lead cross-functional teams and influence senior leadership.•Ability to work collaboratively across functions. Strong interpersonal skills and the ability to build effective working relationships.Additional Requirements:•Ability to work efficiently and make swift decisions in a fast-paced environment, adapting quickly to new challenges and priorities.•Demonstrated commitment to making informed decisions based on scientific evidence and data analysis.•Proven ability to work inclusively with diverse teams, fostering a collaborative environment where all voices are heard and valued.•A humble approach to leadership, always assuming good intentions in others and fostering a positive and respectful work culture.•A proactive attitude with a strong sense of ownership, accountability, and commitment to achieving the organization's goals.Company OverviewMural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Mural Oncology also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Mural Oncology is an E-Verify employer.

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