Director, Compliance

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, Compliance is responsible for establishing and implementing compliance systems related to GxP activities in accordance with applicable global regulations.

• Ensures policies and procedures are in place that support

• the reporting and review of Quality metrics and systems,

• supplier qualification and audit programs,

• risk identification and management,

• data integrity

• Quality planning and management review

• e-Compliance of GxP computer systems

• Provides expertise on all GxP regulations and standards

• Ensures quality systems are compliant with global regulatory requirements.

Responsibilities:

• Assures that all GxP processes are conducted in compliance with applicable regulations and requirements.

• Directs and provides oversight for Internal and External audit program, including routine reporting of progress to plan

• Responsible for HilleVax Third Party Supplier Qualification Program

• Develops and oversees appropriate Quality metrics and reporting on the state of GxP compliance to include reporting at quarterly Quality Management Review

• Manages GxP inspections and audits at HilleVax GxP site(s) from both regulatory authorities and collaborators and provides follow-up responses for all aspects of the business.

• Responsible for implementing and managing Compliance processes and strategy, identifying quality and compliance issues relevant to products in development and providing accurate and timely recommendations to management and Project Team(s).

• Actively represent Quality input at cross-functional team meetings.

• Provides Quality oversight of CMOs and GxP service providers including, approval of suppliers, auditing, quality agreements and monitoring of performance

• Provides Quality oversight of investigations and CAPA.

• Manages contract support that may be required to support execution of QA responsibilities.

• Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, or other departments

• Review and communicate current & emerging regulatory requirements (US and international regulations and guidelines).

Education, Experience & Skills:

• Minimum of a Bachelor's degree in a Science Field; Advanced degree in Science desirable or equivalent industry experience.

• A minimum of 10 years' experience in a pharmaceutical/biologics company with at least five (5) in a leadership role

• Experience with biologics/vaccines is preferred

• Strong understanding of GxP Quality for pre-clinical, clinical, and commercial stage work.

• Expert knowledge and experience in implementing global GxP regulations.

• Experience implementing and ensuring quality compliance (e.g., auditing, vendor management, global inspection readiness, Quality Risk Management, Quality Plan.)

• 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, Hybrid - US East Coast preferred

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

• Excellent verbal, written and organization skills

• Proficient with Microsoft Office applications, Adobe, QMS e-Systems (Veeva Vault experience preferred)

• 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 third-party sites, including overnight trips.

• Some international travel may 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.