Associate Director, Quality Systems

Boston, MA, United States

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, Quality Systems 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 Document Management and Training Management systems, including implementation of electronic systems

Develops and Maintains the Training program

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, Quality Systems 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 Document Management and Training Management systems, including implementation of electronic systems

Develops and Maintains the Training program

Areas of remit include, but are not limited to, document management, learning management, inspection readiness, electronic system implementation, process document authoring, training material development/delivery, metrics generation/communication, and support of change control, deviation investigation/root cause analysis, corrective and preventive action (CAPA), and supplier qualification.

This role supports all Quality activities to ensure compliance with regulatory requirements, company SOPs, and all team objectives. The Associate Director supports efforts across multiple areas to accomplish goals, providing guidance and influencing the organization. They ensure operational decisions made by leadership are executed in a timely manner.

This role will support all GxP areas to ensure compliance of HilleVax programs to phase-appropriate GxPs, global legal/regulatory requirements, and applicable HilleVax Quality policies/procedures.

Key competencies for this role: the candidate must be disciplined, possess a keen eye for detail, and exhibit impressive learning agility, while being able to develop and mentor junior talent. They need to be able to problem solve, prioritize, and provide solutions for complex issues. The role requires ease with coordinating multiple processes simultaneously and the ability to communicate those process specifics clearly and enthusiastically.

Responsibilities: Manage Document/Training Team responsible for: routing and coordinating controlled documents for creation, revision, and obsoletion

routing, documenting, and tracking GxP training activities including departmental curricula and individual training plans/matrices

Training material development and delivery

providing primary Customer Service point of contact for technical questions relating to the Quality systems and related processes

notifying staff of new, revised, or obsolete controlled documents or training assignments

maintaining training records

generating metrics and reports

document formatting

biennial (periodic) document review support and reporting

Serve as system owner for document management and training systems Support Electronic Systems Implementation/Rollout and Updates

Serve as business lead for development, continuous improvement efforts, and on-going maintenance of Quality e-Systems including, Document Management and Learning Management.

Liaise with IT technical team and vendors throughout development to ensure business defined acceptance criteria is achieved for all system changes and projects

Lead development of system fixes, enhancements, and upgrades – including developing user requirements

Lead risk assessment execution for implementations, fixes, enhancements, and system upgrades

Ensure high levels of system availability/functionality through effective testing – including user acceptance test script development and test execution

Support Quality Systems Continuous Improvement Support development of streamlined processes and supplemental documents (including procedural document creation or maintenance) governing management and usage of Quality Systems

Assist in the development and delivery of training for Quality Systems

Maintain and distribute QMS related metrics

Drive Quality Systems data quality improvements

Support customer forums with the areas/departments detailing updates, opportunities, obstacles, etc. regarding the systems/processes

Interface with other HilleVax functions to communicate best practices and identify / improve awareness and adoption of Quality systems and processes

Support CAPAs stemming from audits, inspections, deviations and other Quality related assessments, as well as actions stemming from Change Controls

Support audit preparations with respect to Quality Systems

Own investigation of deviations and CAPAs related to Quality Systems

Support change controls related to Quality Systems

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

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

Excellent computer skills and advanced knowledge of Quality Systems. Direct experience with Quality Management Systems, Document Management Systems, and Learning Management Systems Veeva Systems experience preferred

Quality e-system implementation/roll out experience – working with suppliers, system development, training delivery, and user acceptance testing

Statistical reporting capabilities – metrics, key performance indicators and trending

Proficient with Microsoft Office applications, Adobe, and document management templates

Smartsheet experience a plus.

Highly attentive to details and able to work well as part of a team

Exceptional organization skills

Excellent interpersonal effectiveness, written/verbal communication, influencing and negotiation

Formal or technical writing experience

Relational thinker with the ability to communicate new or complex ideas to affected staff with clarity and enthusiasm

Self-motivator with the ability to follow-up on and complete multiple projects simultaneously Ability to work independently

Able to exercise good judgment in prioritizing tasks

Knowledge of regulatory requirements for the pharmaceutical, biotechnology or vaccine industry required

Advanced knowledge of global quality system requirements

Ability to analyze issues and problem solve to support decision making

Ability to establish and maintain good working relationships with other functions and levels within the company and, in some cases, external groups and organizations (vendors, investigators, and other stakeholders)

Location Boson, Hybrid -US East Coast preferred

Travel Requirements: Willingness to travel (5-10%) to various meetings, 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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