Director, Quality Assurance Operations

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.

We are founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health and build a company that equalizes opportunity for people around the world by removing barriers of health inequity. Our aim is to have a global impact on human health; we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases. HIL-214 is our foundational vaccine candidate from which we are building the company.

Objectives / Overview:

The Director of Quality Assurance Operations is responsible for oversight of GMP activities and disposition of clinical supplies. They will be responsible for working in partnership with Technical Operations, and GMP suppliers to assure compliance with HilleVax quality standards and global regulatory authority expectations. The responsibilities also include identifying and mitigating product quality and regulatory compliance risks, as well as further developing Quality Operations processes and controls in compliance with applicable global regulations.

• Act as key Quality partner with other company functional areas, third parties and partners.

• Provides direct Quality Assurance oversight and support for external manufacturing, quality control and product development.

• Performs/oversees disposition of clinical trial materials

• Provides quality assurance input to technology transfer plans, specifications, procedures, processes, and product development plans.

Responsibilities:

• Assure that all processes contributing to the clinical supply are conducted in compliance with applicable regulations and requirements.

• Responsible for compliant, thorough, and accurate batch review / batch disposition.

• Review and approve SOPs, specifications, and other CDMO controlled documents

• Supports the development and maintenance of quality systems supporting GxP operations.

• Support supplier quality management activities, including audits, quality agreement review, and performance management activities

• Provide quality support to Technical Operations and QC functional areas.

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

• Responsible for implementing and managing Quality Assurance processes and strategy

• Provide Quality oversight of CMOs and GMP service providers including, approval of suppliers, auditing, quality agreements and monitoring of performance.

• Provides Quality oversight or ownership Quality records (e.g. Investigations, CAPA, Change Controls, SOPs, Quality Plans, Risk Assessments).

• Authoring of procedures and training materials.

• Responsible for providing Quality operational support for key quality systems (e.g. complaints, document management, training and change control)

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

• Develop and oversee appropriate area specific Quality metrics and reporting on the state of GMP compliance

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

Education, Experience & Skills:

• Minimum of a bachelor's degree in biological sciences; advanced degree in biological sciences desirable

• A minimum of 8 years' experience in a pharmaceutical/biologics company with at least two (2) in a leadership role

• Experience with biologics/vaccines is required

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

• Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU GMP regulations

• Expertise in batch disposition, root cause investigations, change control, commercial manufacturing oversight and regulatory inspections

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

• Ability to actively provide clear quality input to other departments on relevant topics and issues

• Location Remote-US East Coast preferred

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

• Excellent verbal, written and organization skills

• 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 Requirements:

• Willingness to travel (20-25%) to various meetings or third-party sites, including overnight trips.

• Some international travel may be required.