![Hillevax](https://media.trabajo.org/img/noimg.jpg)
Associate Director, Product Quality Leadership
2 months ago
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.
Who referred you to this position? Enter their first and last name here.
What's your citizenship / employment eligibility? *
Are you 18 years of age or older?
Desired salary *
References: Please enter names and contact information:
#J-18808-Ljbffr
We have other current jobs related to this field that you can find below
-
Associate Director, Quality Assurance
1 month ago
Boston, United States Rhythm Pharmaceuticals Full timeJob DescriptionJob DescriptionCompany OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients...
-
Director, Investment Product
3 weeks ago
Boston, United States Soteriare Full timeDirector, Investment Product Location: Boston, MA Time Type: Full time Posted on: 8 Days Ago Job Requisition ID: 2097531 Job Description: The Director, Investment Product will be responsible for managing and leading due diligence efforts associated with Fidelity’s alternatives strategies. Most notably, the role will focus on managing the firm’s virtual...
-
Director of Quality and Outcomes
1 month ago
Boston, Massachusetts, United States Boston Children's Hospital, Department of Cardiology Full timeBoston Children's Hospital (BCH) seeks to recruit an academic pediatric cardiologist to serve as Director of Quality and Outcomes in the Department of Cardiology with additional responsibilities in the Heart Center. The Director will report to the Chair of the Department of Cardiology. This Director will provide leadership, strategic direction, and...
-
BOSTON, United States Disability Solutions Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Director, Investment Product
2 months ago
Boston, United States Fidelity TalentSource LLC Full timeJob Description:The Director, Investment Product will assist in the product strategy, development, management, and advocacy of Fidelity s suite of investment products and services we make available to institutional customers. \u00A0The primary focus of this role will be in support of our institutional solutions business for the Fidelity Asset Management...
-
Associate Director/Director, Quality Systems
2 weeks ago
Boston, United States Fusion Pharmaceuticals Full timeFusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes:...
-
Associate Director, Quality Systems
4 days ago
Boston, United States Verve Therapeutics, Inc. Full timeJob DescriptionJob DescriptionThe CompanyVerve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease,...
-
Director, Investment Product
2 months ago
Boston, United States Fidelity Investments Full timeJob Description : The Director, Investment Product will assist in the product strategy, development, management, and advocacy of Fidelity’s suite of investment products and services we make available to institutional customers. The primary focus of this role will be in support of our institutional solutions business for the Fidelity Asset Management...
-
Director of Product Merchandising
2 days ago
Boston, United States Planet Interactive Full timeJOB DESCRIPTION: Location: Boston, MassachusettsPay: Up to $65/hour (DOE)Duration: 5 Months Planet Interactive is seeking a Director of Product Merchandising to join a global product merchandising team for a well-known company in the retail industry. This is an onsite, contract role based in Boston with the ability to work remotely on Fridays.The ideal...
-
Director of Product Merchandising
3 days ago
Boston, United States Planet Interactive Full timeJOB DESCRIPTION: Location: Boston, MassachusettsPay: Up to $65/hour (DOE)Duration: 5 Months Planet Interactive is seeking a Director of Product Merchandising to join a global product merchandising team for a well-known company in the retail industry. This is an onsite, contract role based in Boston with the ability to work remotely on Fridays.The ideal...
-
Director, Investment Product
3 weeks ago
Boston, United States National Black MBA Association Full timeJob Description:The RoleThe Director, Investment Product will be responsible for managing and leading due diligence efforts associated with Fidelity’s alternatives strategies. Most notably, the role will focus on managing the firm’s virtual data rooms across Fidelity’s alternatives strategies, which will include:Preparing and reviewing key documents...
-
Associate Director
2 months ago
Boston, United States Khoury College Full timeAbout the OpportunityJob SummaryAbout the College of Arts, Media and DesignWe are a vibrant community of creators, designers, technologists, and communicators applying creativity across disciplines and harnessing emerging technologies to advance human potential and solve the challenges of the future.Powered by experience-driven teaching, learning and...
-
Director Product Manager
2 months ago
Boston, Massachusetts, United States AutoStore Full timeThe Director of Product Management will lead the product management team to drive the development, implementation, and management of product strategies. This role requires a strategic thinker with a keen understanding of market trends and customer needs, capable of delivering innovative products that align with the company's vision and goals.Key...
-
Associate Director, Community Fundraising
4 weeks ago
Boston, United States Mass General Brigham Full timeDescription: As a key member of the Special Events team in Massachusetts General Hospitals Development Office, the Associate Director of Development, Community Fundraising is responsible for managing the highly visible Mass General BeCause Community Fundraising Program, which raises $7 million annually. The Associate Director will work closely with all...
-
Sr. Quality Engineer
2 months ago
Boston, United States BRIOHEALTH SOLUTIONS INC Full timeJob DescriptionJob DescriptionSenior Quality Engineer – Production Quality (onsite)At BrioHealth Solutions, we push the limits of what technology can do to improve lives for patients suffering from advanced heart failure by challenging ourselves and each other to make tomorrow better than yesterday. We need fresh ideas and inclusive insights to continue to...
-
Director Quality Assurance Engineer
2 weeks ago
Boston, United States Staffing Opportunities Solutions, Inc. Full timeTitle: Director Software Quality Assurance Engineer Job Type: Full-Time PermanentLocation: 100% Remote WorkStaffing Opportunity Solutions is engaged with a dynamic B2B software client experiencing tremendous growth! Ideally looking for experience in Microsoft technologies, testing & automation in the SaaS or cloud environments, and strong team leadership....
-
Director of Video Production
2 months ago
Boston, Massachusetts, United States Boston Bruins Full timeThe Opportunity The Boston Bruins Director of Video Production is responsible for overseeing and managing all programming for the organization, which includes, but is not limited to, "Behind The B," "Bruins Academy" and all video content that is distributed on the team's social media platforms. This role involves identifying new programming opportunities,...
-
Boston, United States Dana-Farber Cancer Institute Full timeJob ID: 40187 Location: 10 Brookline Place West, Brookline, MA 02445 Category: Clinical Research Employment Type: Full time Work Location: Remote: occasional time on campus Overview This position's work location is fully remote with occasional onsite time as needed. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT,...
-
Director, Investment Product
1 month ago
Boston, United States Fidelity TalentSource LLC Full timeJob Description:The RoleThe Director, Investment Product will be responsible for managing and leading due diligence efforts associated with Fidelity s alternatives strategies. Most notably, the role will focus on managing the firm s virtual data rooms across Fidelity s alternatives strategies, which will include:Preparing and reviewing key documents from...
-
Director of Product Marketing
4 days ago
Boston, United States Zoovu Ltd Full timeZoovu is empowering people to find the products and services they need by building the world’s most intelligent search and product discovery platform. We’re assembling a team that can help us achieve this ambitious mission, revolutionize an industry, and shape a world-class culture. We work with hundreds of the world's largest ecommerce brands, like...