Senior Director, Clinical Quality Assurance

Altimmune•Gaithersburg, MD

About The Position

Altimmune (NASDAQ: ALT) is a late clinical-stag e biopharmaceutical company developing therapies for patients with serious liver diseases. The Company's lead candidate, pemvidutide, is a unique dual-action therapy targeting both glucagon and GLP-1 receptors in a balanced 1:1 ratio in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). For more information, please visit www.altimmune.com . Job Description : The Senior Director, Clinical Quality Assurance (CQA) leads the strategy, oversight, and execution of the company's global Good Clinical Practice (GCP) quality program. This role oversees from the Quality perspective all clinical trials and ensures that, especially late‑phase (Phase III) global studies, are conducted in compliance with ICH‑GCP, regulatory expectations, industry best practices and internal quality standards. The Senior Director, along with the VP, Quality and Compliance Management, will help build and mature the CQA function, oversee vendor and site quality, including audits, and serve as a key partner to Clinical Operations, Regulatory, Pharmacovigilance, Clinical Development, Biostatistics, Data Management, and external partners. This position performs reviews of clinical documentation, processes and systems, working to identify and mitigate risk. The Senior Director will promote a quality-oriented culture throughout the organization. The position will manage the Associate Director, Clinical Quality and will report to the VP, Quality and Compliance Management.

Requirements

A Bachelor's Degree in Science, Health Care or a related discipline required. Advanced degree preferred.
Minimum of 15 years of relevant experience in a quality, clinical development, or clinical operations role in the biopharmaceutical industry
10 years of experience in ICH/GCP/GCLP/CAP/CLIA guidelines/regulations and clinical quality assurance with a minimum of 5 years of global clinical quality assurance experience.
Extensive experience supporting global clinical trials, including Phase III pivotal studies.
Experienced in Clinical Quality auditing. ASQ, Auditor, or Clinical Professional certification preferred.
Deep knowledge of US, EU and International regulatory standards, ICH, and GxP Guidelines for the conduct of clinical trials.
Global regulatory inspection experience (FDA, EMA, MHRA, PMDA, Health Canada, etc.) preferred.
Experience with CRO oversight preferred.
Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization to provide solutions to complex situations.
Strong technical writing skills.
Ability to build strong collaborative relationships with partners inside and outside of the organization.
Excellent communication and interpersonal skills for effectively interfacing with internal and external personnel at all levels.
Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment.
Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations.
Excellent problem-solver with the ability to work independently.
Excellent attention to detail.
Proficient use of MS PowerPoint, Excel and Word.
Familiarity with digital systems (eTMF, CTMS, QMS platforms).
Travel up to 25% of time.

Responsibilities

Strategic Leadership & Quality Governance Help develop and execute the global CQA strategy aligned with company goals and regulatory expectations.
Maintain a robust GCP Quality Management System (QMS).
Proactively identify potential GCP risks, complete risk-based QA assessments, and support the implementation of associated risk mitigation strategies.
Develop and maintain GCP/ICH compliant processes for clinical trials.
Lead the Clinical Quality Assurance team which includes third party contractors.
Provide GCP expertise within the company as well as externally to vendors and service providers as appropriate.
Review relevant study team, regulatory and project documentation for compliance with GCP, industry and corporate standards.
Maintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines and practices and ensure that the information is distributed to relevant parts of the Altimmune organization.
Champion a culture of quality, transparency, and accountability across the organization.
Oversight of Global Clinical Trials (Phase I–III, with emphasis on Phase III) Provide quality oversight for global, multi‑regional Phase III trial(s), ensuring inspection readiness at all times.
Support vendor qualification, selection, and ongoing oversight.
Ensure timely identification, escalation, and resolution of quality issues, deviations, and systemic risks.
Partner with Clinical Operations to ensure protocol compliance, data integrity, and patient safety.
Provide day to day clinical study team support, including managing Associate Director, QA.
Audit & Inspection Management Participate in inspections performed by FDA and international regulatory agencies and serve as GCP lead in such regulatory inspections (FDA, EMA, MHRA, PMDA, etc.).
Guide teams in responding to regulatory findings and implementing sustainable corrective and preventive actions (CAPA).
Ensure the implementation of effective CAPA to address audit observations.
Lead qualification, routine, and for-cause audits and/or provide input for audits performed by contractors of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors as well as other clinical vendors.
Clearly communicate and report audit outcomes and observations as appropriate to Company, and escalate clinical quality issues to leadership as warranted.
Conduct or assist with Clinical Study Report and Trial Master File audits and/or direct audits performed by contractors.
Lead or assist with internal quality audits.
Ensure timely issuance of audit reports, oversee the audit response process, and drive audits to closure.
Quality Systems & Continuous Improvement Review vendor supplied data and quality records for conformance to requirements and good documentation practices (GDP).
Write standard operating procedures (SOPs) and initiate SOP revisions to improve compliance and improve processes.
Implement quality metrics and dashboards to monitor compliance, drive continuous improvement, and support Quality Management Reviews.
Ensure clinical study quality incidents and deviations are fully investigated, root cause analysis is performed, and corrective and preventive actions are implemented and monitored for effectiveness.
Provide input for GCP training and assist in providing training to staff involved with Altimmune's clinical trials.