Director, Clinical Quality Assurance

HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens. HIL-214 has been studied in eight Phase I/II studies in more than 4,500 subjects. HilleVax is currently planning initiation of a Ph 2b study in infants.

We are a rapidly growing and dynamic organization that is founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health. Our goal is to build a company that equalizes opportunity for people around the world by removing barriers of health inequity, and we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases.

Objectives / Overview:

The Director of Clinical Quality (Research Compliance) is responsible for the management and oversight of quality assurance (QA) activities to ensure compliance of HilleVax-sponsored phase 1 through phase 3 clinical trials with Good Clinical Practices (GCP), applicable global regulations, and internal HilleVax policies and procedures.

• Act as key Quality partner with HilleVax functional areas, external CROs and other suppliers

• Provide QA oversight and support for the internal and external clinical activities, specifically in the areas of clinical trial conduct and data management, for all HilleVax product development programs (e.g., late phase norovirus vaccine development in Infants/Children and Older Adults & High Risk Populations; early phase development of in-licensed and next generation products)

• Provide expertise on GCP regulations, standards, and quality systems

• Lead the buildout of the Research Compliance arm of Clinical Quality as needed, including recruitment and management of personnel, to support HilleVax growth and corporate strategy

• Support and actively contribute to HilleVax Quality department team, objectives, and initiatives

Responsibilities:

• Assure that processes contributing to the performance of a clinical trial are conducted in compliance with applicable regulations and requirements by means of:

• Trial-specific Audit Program Planning and Management & QA Document Reviews

• Develop risk-based Trial-specific Audit Plans and manage their execution, including conducting or overseeing the following activities: resourcing to qualified auditors, audit plan development, audit conduct, audit reporting, audit report distribution and followup with internal stakeholders, observation issuance, response/CAPA review, and audit closure. Trial-specific audits include but are not limited to Clinical Investigator/Site, Trial Master File, Clinical Study Document/Report, and Data Integrity audits.

• Execute and manage consultant auditor contracts and budgets in compliance with HilleVax policies.

• Ensure HilleVax audit database(s) are up to date, generate metrics, conduct trend analysis, identifying potential areas of risk, and providing reports to management as required.

• Trial-specific Issue Management

• Provide CQA oversight and support for the identification, investigation, escalation, CAPA planning and execution, and reporting of issues and HilleVax deviations per applicable HilleVax SOPs

• Clinical Trial Risk Management

• Execute CQA responsibilities required by HilleVax risk management SOPs, including partnering with Clinical Project Managers on sponsor risk assessment, clinical trial risk review, internal review of trends, and reporting to management

• Collaborate with Clinical Quality Supplier Management lead and internal functional area representatives to ensure that suppliers providing clinical research services are qualified and compliant.

• Collaborate with Clinical Quality Systems lead and internal functional area representatives to ensure that HilleVax processes and procedures are developed or revised as needed

• Provide GCP quality support to clinical research functional areas (e.g., Clinical Development, Clinical Operations, Medical Writing, Medical Monitoring, Data Management, Biostatistics & Programming, Regulatory Affairs, Clinical Supplies Management, Pharmacovigilance)

• Actively represent CQA input at cross-functional and departmental team meetings

• Implement and manage CQA processes and strategy, identifying quality and compliance issues relevant to products in development and providing accurate and timely recommendations to management and project teams

• Provides CQA oversight of investigations and CAPAs

• Provide timely reports to HilleVax management on Research Compliance metrics and state of GCP compliance of HilleVax-sponsored clinical trials

• Manages contract support that may be required in execution of Clinical Quality Research Compliance responsibilities

• Support regulatory health authority GCP inspections of HilleVax studies, serving as internal HilleVax point of contact for inspection preparation, inspection hosting support, inspection report review and follow-up to ensure responses are coordinated and submitted in required timeframe, and CAPAs are developed and executed as appropriate.

• Provide support for other HilleVax CQA/Quality objectives

Education, Experience & Skills:

• Minimum of a Bachelor's degree in a Science Field; Advanced degree in Science desirable

• A minimum of 10 years of clinical quality experience in a pharmaceutical/biologics company with demonstrated increasing expertise and responsibility

• Experience with biologics/vaccines is preferred

• Strong understanding of GCP Quality for clinical and commercial stage work

• Expert knowledge and experience in implementing global regulations in clinical trials

• Experience implementing and ensuring GCP quality (e.g., GCP oversight, auditing, electronic systems management, global inspection readiness

• Demonstrated ability to work efficiently across multiple project teams and business functions

• Ability to actively provide clear quality input to other departments (e.g., clinical) on relevant topics and issues

• Location in Boston preferred; possible remote options

• Able to handle multiple projects and exercise good judgment in prioritizing tasks

• Excellent verbal, written, and organizational skills

• Proficient with Microsoft Office applications, Adobe and document management templates

• Ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (vendors, investigators, regulatory authorities, and other stakeholders)

Travel, Physical Demands & Work Environment:

• Willingness to travel (~20-25%) to various meetings or vendors/sites, including overnight trips.

• Some international travel will be required.

HilleVax is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We welcome all to apply.