Manager/ Sr. Manager, Quality Assurance Operations
2 weeks ago
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 Manager/Senior Manager of Quality Assurance provides oversight of GMP activities for Quality Control Release and Stability testing including method validation and transfer. They will work in partnership with Technical Operations, Quality Control, 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 working to establish 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 the assigned area (e.g. quality control and analytical development).
* Provides quality assurance input to analytical method validation/transfer plans and activities, routine Quality Control release and stability testing, deviation and OOS investigations, stability studies, reference standards, procedures, and processes.
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 documents and QA oversight for laboratory investigations.
* Review and approve SOP's and other third party laboratory controlled documents.
* Supports the development and maintenance of quality systems supporting GxP operations.
* Provide quality support to Technical Operations and/or QC functional areas.
* Executes Quality Assurance processes effectively.
* Provides Quality oversight or ownership Quality records (e.g. Investigations, CAPA, Change Controls, SOPs, Quality Plans, Risk Assessments).
* Authors procedures and training materials.
* Reports appropriate Quality metrics and monitors the state of GMP compliance.
Education, Experience & Skills:
* Minimum of a bachelor's degree in biological sciences; advanced degree in biological sciences desirable
* A minimum of 5 years' experience in a pharmaceutical/biologics company with at least two (2) in third party manufacturing QA
* 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, commerical manufacturing oversight and regulatory inspections.
* 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.
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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