Associate Director, Quality Control - Lifelancer

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 Companys 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.

Detailed 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 Associate Director of Quality Control is responsible for overseeing quality control (QC) activities, including the stability program for biologics across our external testing laboratories. This role ensures that all quality control activities at contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs) for both clinical and commercial manufacturing align with cGMP standards, Quality Agreements, regulatory requirements, and Mural Oncologys Quality Management System (QMS). Key responsibilities include ensuring compliance with EU/FDA and associated guidelines for analytical support in biologic drug development programs, maintaining rigorous oversight of CMOs/CTLs to ensure adherence to regulatory requirements and company standards, and fostering consistency in CMO/CTL management for analytical quality-related activities. This role is critical in supporting Mural’s commitment to high-quality, regulatory-compliant drug development and manufacturing.

Job Responsibilities:

QC Oversight and Batch Release Support:

• Conduct comprehensive reviews of batch records for drug substances and drug products, ensuring alignment with GMP and regulatory standards prior to release.
• Review and approve Certificates of Analysis (COAs) for clinical and commercial products to confirm compliance with critical quality attributes and specifications.
• Provide final QC approval on critical documentation related to batch release, including in-process, and release of analytical testing data and necessary quality certifications for distribution.
• Develop, maintain and approve sampling plans for manufacturing processes.
• Author, review, and approve various documents, including SOPs, CoAs, technical reports, stability reports for regulatory filings, change controls, deviations, CAPAs, OOSs, and OOTs.
• Perform quality reviews and approval of PPQ and commercial product manufacturing documentation (e.g., Quality batch records, validation protocols and reports).

Stability Program Management Compliance:

• Manage commercial stability program including establishment of shelf life.
• Oversee stability programs to ensure timely testing, real-time trending, and generation of stability reports.

Testing and Method Validation Oversight:

• Develop and execute QC strategies for method qualification, transfer, and validation in partnership with Analytical Development and other key roles (e.g., Product Quality Leads).
• Oversee the verification, qualification, and validation of analytical methods, working closely with QC teams to address any issues that arise during manufacturing or testing.
• Develop monitoring measures for method/testing aspects, including in-process, release, stability testing, OOT/OOS results, and escalate any significant trends.
• Coordinate the compilation, review, and submission of Annual Product Quality Review (APQR) information from CMOs and CTLs.
• Maintain and approve product release specifications for DS/DP.

Regulatory Compliance and Support:

• Support the Regulatory and CMC teams by providing quality input for license applications (e.g., IND, IMPD, MAA, BLA) and regulatory filings, particularly for analytical sections, coordinating reviews with CMOs and CTLs as needed.
• Assist with regulatory inspections at internal sites, CMOs, and CTLs, ensuring readiness and addressing any compliance risks.

Quality Investigations and Continuous Improvement:

• Oversee, review, approve and ensure thorough investigation of out-of-specification (OOS) and out-of-trend (OOT) results, coordinating with QC teams to identify root causes and implement corrective and preventive actions (CAPAs).
• Manage investigations for significant deviations and quality incidents related to testing or batch issues at CMO and CTL sites, ensuring thorough resolution to maintain product quality and compliance.
• Develop and monitor key performance indicators (KPIs) specific to QC activities, analyzing quality metrics to drive continuous improvement aligned with Mural Oncology’s quality objectives.
• Participate in Quality Review Board meetings, representing QC to communicate trends, issues, or risks related to vendor performance. This includes preparing and presenting reports to cross-functional teams and senior leadership.

Quality System Management:

• Ensure adherence to quality systems, quality agreements, and compliance with applicable regulatory standards and internal procedures at CMOs and CTLs.
• Provide QC oversight for change management processes, assuming oversight of change controls to ensure clarity in scope and timely, effective implementation.

Vendor and Stakeholder Relationship Management:

• Build and maintain effective working relationships with internal stakeholders, CMOs, and CTLs, fostering collaboration and alignment on quality, analytical, and compliance activities.
• Ensure that all quality agreements with CMOs and CTLs align with regulatory expectations and Mural Oncology’s quality standards.

Process and Product Quality Support:

• Provide quality oversight for all Process Performance Qualification (PPQ) activities related to drug substances and drug products, including process characterization, cleaning validation, process validation, analytical method validations, and testing activities.
• Manage and oversee the clinical and commercial stability studies, hold time studies, and review and approval of related protocols, ensuring compliance with regulatory and quality standards throughout the product lifecycle.

Audits and Inspection Readiness:

• Support the Inspection Readiness Program to maintain adherence to regulatory requirements and internal quality standards.
• Participate in internal and third-party audits, respond to quality system-related findings, and take appropriate actions to ensure GxP compliance.
• Represent Quality Control processes during internal audits and external inspections.

Budgeting:

• Assist with determining budgetary requirements for CTLs managed by Quality, supporting efficient allocation and utilization of resources.

Qualifications:

• Bachelor’s degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality orientation.
• 10+ years’ experience in the pharmaceutical industry; preferably in biologics in all stages of development thought commercialization.
• Hands-on industry experience in Quality Control authoring, reviewing, and approving various release, stability of drug substance and drug product assays in GMP setting including upstream and downstream GMP Drug Substance manufacturing, Drug product and IVSS testing manufacturing activities.
• Demonstrated experience in external QC oversight, including managing QC teams and/or initiatives.
• Proficiency in data analysis and KPI development to support quality metrics and continuous improvement.
• In-depth knowledge of GMP regulations, US FDA and European regulatory requirements, ICH Guidelines, and Quality System Regulations.
• Strong technical expertise in analytical development requirements specific to biologics.
• Experience in development and CMO/CTL operations, including oversight of contracted organizations and auditing experience.
• Proven experience preparing for and managing regulatory inspections (e.g., FDA, EMA) for QC and Analytical QA activities.
• Strong background and understanding of various analytical methods such as SEC-HPLC, RP HPLC, IEX, SDS-Page, cIEF, compendial assays as well as ELISA (Plate base assay), potency assay (cell-based assays) and qPCR testing.
• Strong interpersonal, leadership, project management, and problem-solving skills, with demonstrated ability to manage stakeholders and communicate effectively.
• Risk management skills, with experience assessing and mitigating risks within a GMP-regulated environment.
• Experience with process management and implementing continuous improvement initiatives
• Ability to travel domestically up to 20%.