Director of Quality Operations

10 hours ago

Waltham, Massachusetts, United States Mural Oncology Full time
Job Title: Director Quality Operations

Mural Oncology is a clinical-stage oncology company focused on discovering and developing immunotherapies that may improve the lives of patients with cancer. Our team 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).

Job Summary:

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.

Key Responsibilities:
  • 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.
  • 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.
Requirements:
  • 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.

Mural 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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