Director, Clinical Quality Assurance

6 days ago

Boston, United States HilleVax, Inc. Full time

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.

  • Director of Quality Assurance

    4 weeks ago

    Boston, United States Albion Rye Associates Limited Full time

    Director, Clinical Quality Assurance Location: Boston, Massachusetts Albion Rye Associates are partnered with one of the fastest growing US Biotech's with a rich Clinical pipeline across various indications to recruit a Director / Snr Director, Clinical Quality Assurance. Leading a small team, you will be part of the Quality Assurance management function,...

  • Director of Quality Assurance

    4 weeks ago

    Boston, United States Albion Rye Associates Full time

    Director, Clinical Quality AssuranceLocation: Boston, Massachusetts Albion Rye Associates are partnered with one of the fastest growing US Biotech's with a rich Clinical pipeline across various indications to recruit a Director / Snr Director, Clinical Quality Assurance.Leading a small team, you will be part of the Quality Assurance management function,...

  • Director, Clinical Quality Assurance

    1 week ago

    Boston, United States Hillevax Full time

    Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications. 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...

  • Director of Quality Assurance

    4 weeks ago

    Boston, United States Walker Cole International Full time

    Walker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA.As the Director of Quality Assurance, you will be responsible for:Leadership of entire QA function including QA Systems, Quality Ops and Validation Participation in internal/external audits and...

  • Director, Quality Assurance Operations

    5 days ago

    Boston, United States Hillevax Full time

    Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications. 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...

  • Director, Quality Assurance Operations

    7 days ago

    Boston, United States HilleVax, Inc. Full time

    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...

  • Executive Director, Quality Assurance, GMP

    1 month ago

    Boston, United States Xenon Pharmaceuticals Inc. Full time

    Executive Director, Quality Assurance, GMP Boston, MA, USA Req #267 Monday, May 13, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric...

  • Director, Quality

    2 months ago

    Boston, United States Commonwealth Care Alliance Full time

    **Why This Role is Important to Us**: **Position Summary**: The Director, Quality & Control Assurance reports to the VP of Quality & Control Assurance is responsible for providing strategic leadership and oversight for the Quality & Control Assurance within CCA’s Compliance department. This position designs, continually matures, promotes, & develops a...

  • Director, Quality

    3 weeks ago

    Boston, United States Commonwealth Care Alliance Full time

    Why This Role is Important to UsPosition Summary: The Director, Quality Control Assurance reports to the VP of Quality Control Assurance is responsible for providing strategic leadership and oversight for the Quality Control Assurance within CCA's Compliance department. This position designs, continually matures, promotes, develops a program that adheres to...

  • Quality Assurance Manager

    3 weeks ago

    Boston, United States The Brookline Center for Community Mental Health Full time

    QUALITY ASSURANCE MANAGER If you’re excited about driving change and passionately believe that all people deserve access to quality behavioral health care, we have an amazing opportunity for you! We’re looking for people who want to be part of a fast-paced and entrepreneurial team that is transforming a long-respected community mental health center into...

  • Quality Assurance Manager

    1 month ago

    Boston, United States The Brookline Center for Community Mental Health Full time

    QUALITY ASSURANCE MANAGER If youre excited about driving change and passionately believe that all people deserve access to quality behavioral health care, we have an amazing opportunity for you! Were looking for people who want to be part of a fast-paced and entrepreneurial team that is transforming a long-respected community mental health center into a...

  • Quality Assurance Manager

    1 month ago

    Boston, United States The Brookline Center for Community Mental Health Full time

    QUALITY ASSURANCE MANAGERIf you’re excited about driving change and passionately believe that all people deserve access to quality behavioral health care, we have an amazing opportunity for you! We’re looking for people who want to be part of a fast-paced and entrepreneurial team that is transforming a long-respected community mental health center into a...

  • Executive Director, Quality Assurance, GMP 2034727

    11 hours ago

    Boston, United States Stratacuity: Proven Scientific Placement Full time

    Location: Boston, MA (Hybrid)Science: Small Molecule TherapeuticsJob Overview: The Executive Director, Quality Assurance, GMP will oversee internal and external GMP quality and leverage extensive quality and manufacturing experience from all clinical phases into commercialization.Primary Job Responsibilities:Lead quality assurance for CMO-related activities,...

  • Director of Quality Assurance

    6 days ago

    Boston, United States Sci-Rec Full time

    Head of Quality Assurance - Boston Do you want to join a growing biologics CDMO based in Boston, MA and help the team to achieve their site goals of considerable growth over the next 5 years? If so, apply below. Responsibilities: Maintaining site's Quality system in accordance with regulatory guidelines and cGXP compliance requirements; Maintaining the high...

  • Associate Director, Clinical Data Management

    2 weeks ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    2 weeks ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Companys Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH) Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    2 weeks ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Director of Quality Assurance

    3 weeks ago

    Boston, United States Sci-Rec Full time

    Head of Quality Assurance - BostonDo you want to join a growing biologics CDMO based in Boston, MA and help the team to achieve their site goals of considerable growth over the next 5 years? If so, apply below.Responsibilities:Maintaining site's Quality system in accordance with regulatory guidelines and cGXP compliance requirements;Maintaining the high...

  • Director of Quality Assurance

    2 weeks ago

    Boston, United States Sci-Rec Full time

    Head of Quality Assurance - BostonDo you want to join a growing biologics CDMO based in Boston, MA and help the team to achieve their site goals of considerable growth over the next 5 years? If so, apply below.Responsibilities:Maintaining site's Quality system in accordance with regulatory guidelines and cGXP compliance requirements;Maintaining the high...

  • Director, Quality Assurance

    1 month ago

    Boston, United States Fresenius Kabi USA, LLC Full time

    Job Summary The Director, Quality Assurance will manage quality projects, lead Continuous Improvement initiatives, and will drive change to further integrate and implement Ivenix Infusion System into the Fresenius Kabi organization and systems. A key aspect will be to ensure compliance with the U.S. regulatory requirements and FDA expectations are met. This...