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Associate Director, Supplier Quality and Auditing
3 months 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. 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 Associate Director, Supplier Quality & Auditing provides leadership and expertise on quality systems applications, procedures, and operational activities.
- Acts as a key Quality partner with other company functional areas, third parties and partners.
- Performs as Quality system owner for Supplier Qualification and Auditing systems, including implementation of electronic systems
- Develops and Maintains the Supplier Quality Management program
- Manages inspection readiness activities, as well as internal and external audits and inspections
- Lead qualification of GxP suppliers including, approval of suppliers, auditing, quality agreements and monitoring of performance.
- Develop and maintain relationships with department functions internally and collaborate on audit plans in line with the scope of services offered by suppliers
- Oversee and manage all auditing activities, including planning, execution, and follow-up of supplier audits.
- Ensure thorough documentation and reporting of audit findings, and track corrective and preventive actions (CAPA)
- Manage the development and maintenance of quality agreements with all suppliers to ensure clear expectations and compliance requirements are met.
- Collaborate with legal, procurement, and operational teams to align quality agreements with overall business objectives.
- Facilitates the development and maintenance of applicable quality systems supporting Supplier Qualification and Auditing, including overseeing the design, development, roll-out and maintenance of e-systems.
- Manages internal and external inspections and audits at HilleVax, including inspection readiness activities.
- Authoring procedures and training materials.
- Provides Quality oversight or ownership of Quality records (e.g. Investigations, CAPA, Change Controls, SOPs, Quality Plans, Risk Assessments and Complaints).
- Manages contract support that may be required to support execution of QA responsibilities.
- Develop and oversee appropriate Quality metrics and support management review of the state of GxP compliance
- 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 8 years' experience in a pharmaceutical/biologics company with at least two (2) in a leadership role
- Experience with biologics/vaccines is preferred
- Expert auditing experience required
- Advanced knowledge and experience in implementing electronic Quality Systems, Veeva experience preferred
- Strong knowledge of global regulatory requirements
- Demonstrated ability to work efficiently across multiple project teams and business functions
- Location 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 Requirements:
- Willingness to travel (10-20%) 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.
