Associate Director, Product Quality Leadership

Boston, MA, United States

Associate Director, Product Quality Leadership 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 Associate Director Product Quality Leadership (Quality Assurance) provides oversight of GMP product quality. They will work in partnership with Technical Operations, Quality Control, Regulatory Affairs, and GMP suppliers to assure compliance with HilleVax quality standards and global regulatory authority expectations. The responsibilities include identifying and mitigating product quality and regulatory compliance risks, as well as working in partnership with Regulatory Affairs to ensure compliance with applicable global regulations.

Provides quality oversight for in-depth end to end technical knowledge of the product

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

Provides direct Quality Assurance oversight and support for the assigned area (e.g. Product Quality)

Provides quality assurance input for tech and analytical transfer/validation activities, deviation and OOS investigations that require oversight of product quality, stability studies, reference standards, specifications, procedures, and processes, etc

Serving as quality lead for product/program teams, including quality lead for CMC regulatory filings

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 Associate Director Product Quality Leadership (Quality Assurance) provides oversight of GMP product quality. They will work in partnership with Technical Operations, Quality Control, Regulatory Affairs, and GMP suppliers to assure compliance with HilleVax quality standards and global regulatory authority expectations. The responsibilities include identifying and mitigating product quality and regulatory compliance risks, as well as working in partnership with Regulatory Affairs to ensure compliance with applicable global regulations.

Provides quality oversight for in-depth end to end technical knowledge of the product

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

Provides direct Quality Assurance oversight and support for the assigned area (e.g. Product Quality)

Provides quality assurance input for tech and analytical transfer/validation activities, deviation and OOS investigations that require oversight of product quality, stability studies, reference standards, specifications, procedures, and processes, etc

Serving as quality lead for product/program teams, including quality lead for CMC regulatory filings

Responsibilities: Ensures all processes contributing to the clinical supply, are conducted in a compliance with applicable regulations and requirements

Responsible for compliant, thorough, and accurate review of analytical and process documents, including QA oversight of investigations within specified area of Product Quality

Review and approve SOP’s, specifications, and other CDMO and internal HilleVax controlled documents

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

Executes Quality Assurance processes effectively

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

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) years of leadership experience

Experience with third party QA desired

Experience with biologics/vaccines is required

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

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

Highly skilled in root cause investigations, change control, commercial manufacturing oversight and regulatory inspections

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

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.

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.

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