![HilleVax, Inc.](https://media.trabajo.org/img/noimg.jpg)
Director, Quality Assurance Operations
1 month 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 Director of Quality Assurance Operations is responsible for oversight of GMP activities and disposition of clinical supplies. They will be responsible for working in partnership with Technical Operations, 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 further developing 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 external manufacturing, quality control and product development.
Performs/oversees disposition of clinical trial materials
Provides quality assurance input to technology transfer plans, specifications, procedures, processes, and product development plans.
Responsibilities:
Assure that all processes contributing to the clinical supply are conducted in compliance with applicable regulations and requirements.
Responsible for compliant, thorough, and accurate batch review / batch disposition.
Review and approve SOPs, specifications, and other CDMO controlled documents
Supports the development and maintenance of quality systems supporting GxP operations.
Support supplier quality management activities, including audits, quality agreement review, and performance management activities
Provide quality support to Technical Operations and QC functional areas.
Actively represent Quality input at cross-functional team meetings.
Responsible for implementing and managing Quality Assurance processes and strategy
Provide Quality oversight of CMOs and GMP service providers including, approval of suppliers, auditing, quality agreements and monitoring of performance.
Provides Quality oversight or ownership Quality records (e.g. Investigations, CAPA, Change Controls, SOPs, Quality Plans, Risk Assessments).
Authoring of procedures and training materials.
Responsible for providing Quality operational support for key quality systems (e.g. complaints, document management, training and change control)
Manages contract support that may be required to support execution of QA responsibilities.
Develop and oversee appropriate area specific Quality metrics and reporting on the state of GMP compliance
Review and communicate current & emerging regulatory requirements (US and international regulations and guidelines).
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) in a leadership role
Experience with biologics/vaccines is required
Strong understanding of GMP Quality for pre-clinical, clinical, and commercial stage work.
Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU GMP regulations
Expertise in batch disposition, root cause investigations, change control, commercial manufacturing oversight and regulatory inspections
Demonstrated ability to work efficiently across multiple project teams and business functions
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.
#J-18808-Ljbffr
We have other current jobs related to this field that you can find below
-
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....
-
Executive Director, Quality Assurance, GMP
2 weeks ago
Boston, United States Xenon Inc Full timeWho We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...
-
Director of Quality Assurance
2 months ago
Boston, United States Sci-Rec Full timeHead of Quality Assurance - BostonDo you want to join a growing biologics CDMO based in Boston, MA and help the team to achieve their site goals of considerable growth over the next 5 years? If so, apply below.Responsibilities:Maintaining site's Quality system in accordance with regulatory guidelines and cGXP compliance requirements;Maintaining the high...
-
Director of Quality Assurance
2 months ago
Boston, United States Sci-Rec Full timeHead of Quality Assurance - BostonDo you want to join a growing biologics CDMO based in Boston, MA and help the team to achieve their site goals of considerable growth over the next 5 years? If so, apply below.Responsibilities:Maintaining site's Quality system in accordance with regulatory guidelines and cGXP compliance requirements;Maintaining the high...
-
Claims Director, Casualty
3 hours ago
Boston, United States Plymouth Rock Assurance Full timeReporting directly to the Vice President of Claims, the Director will oversee our MA and NH casualty and medical claim operations. The Director will have oversight of four casualty and two medical teams and will ensure that claims are handled in a timely and efficient manner. You will be expected to manage litigation activities, 93A process and stay current...
-
Director of Quality Assurance
1 week ago
Boston, United States RBW Consulting Full timeRBW is partnering with an innovative biopharma company in its search for a Director of Quality. Our client has several biologics products on the market, with a strong development pipeline and is providing the right candidate with the opportunity to work with a rapidly growing organisation.The candidate will report directly to the executive team, and this...
-
Director of Quality Assurance
2 months ago
Boston, United States RBW Consulting Full timeRBW is partnering with an innovative biopharma company in its search for a Director of Quality. Our client has several biologics products on the market, with a strong development pipeline and is providing the right candidate with the opportunity to work with a rapidly growing organisation.The candidate will report directly to the executive team, and this...
-
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...
-
Quality Assurance Specialist
2 months ago
Boston, United States Arcaea Full timeJob DescriptionJob DescriptionArcaea is a biology-first beauty company building a new ingredient toolset for the beauty and personal care industry. We are creating pioneering ingredients, products, and stories accessible uniquely through biology. Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in...
-
Senior Specialist, Quality Assurance
4 weeks ago
Boston, United States GQR Full timeTitle: Sr. Specialist, Quality AssuranceLocation: Boston, MA Seaport districtHybrid; 3 days a week onsite, 2 remoteStatus: contract through end of yearHourly rate: $58This Quality Assurance role requires experience in biotech and biologics. Only candidates with this experience will be considered.Candidates must reside in Massachusetts. The Sr. QA Specialist...
-
Boston, United States Stratacuity: Proven Scientific Placement Full timeLocation: Boston, MA (Hybrid)Science: Small Molecule TherapeuticsJob Overview: The Executive Director, Quality Assurance, GMP will oversee internal and external GMP quality and leverage extensive quality and manufacturing experience from all clinical phases into commercialization.Primary Job Responsibilities:Lead quality assurance for CMO-related activities,...
-
Boston, United States Stratacuity: Proven Scientific Placement Full timeLocation: Boston, MA (Hybrid)Science: Small Molecule TherapeuticsJob Overview: The Executive Director, Quality Assurance, GMP will oversee internal and external GMP quality and leverage extensive quality and manufacturing experience from all clinical phases into commercialization.Primary Job Responsibilities:Lead quality assurance for CMO-related activities,...
-
Pharmacy Technician, Quality Assurance
2 weeks ago
Boston, United States Dana-Farber Cancer Institute Full timeJob ID: 40095 Location: 450 Brookline Ave, Boston, MA 02215 Category: Pharmacy Employment Type: Full time Work Location: Onsite: 4-5 days onsite/week Overview The Pharmacy Department at the Dana-Farber Cancer Institute places emphasis on the values of reliability, professionalism, cooperation, teamwork, communication, positivity and inclusiveness. The...
-
Quality Assurance Engineer
4 weeks ago
Boston, Massachusetts, United States Altoida Full timePosition Overview The Quality Assurance Engineer (QAE) will lead the implementation, continuous improvement and maintenance of the Quality Management System for a Software as a Medical Device product to meet the requirements of the FDA's Quality System Regulation, ISO 13485 and other software standards and Regulatory requirements as required. Partner with...
-
Quality Assurance Specialist
4 weeks ago
Boston, United States Futura Energy Group Full timeWe are delighted to be partnered with a leading clean energy company who are looking for a QA Specialist to join their team. The Quality Assurance Specialist is tasked with supervising and coordinating all Quality Assurance activities for a POD under construction, ensuring compliance with design and specification parameters. Responsibilities include...
-
Quality Assurance Specialist
4 weeks ago
Boston, United States Futura Energy Group Full timeWe are delighted to be partnered with a leading clean energy company who are looking for a QA Specialist to join their team. The Quality Assurance Specialist is tasked with supervising and coordinating all Quality Assurance activities for a POD under construction, ensuring compliance with design and specification parameters. Responsibilities include...
-
Software Quality Assurance
4 weeks ago
Boston, Massachusetts, United States State Street Full timeSoftware Quality Assurance positionThis opportunity is for an experienced software professional at State Street Bank and Trust Company in Boston, Massachusetts. The role involves collaborating on State Street's internal Enterprise Servicing Platform, a data warehouse tool. The ideal candidate must possess a strong understanding of leading IT technologies and...
-
Manager, Accounting Operations
2 months ago
Boston, United States Plymouth Rock Assurance Full timeOverview: Plymouth Rock Assurance is looking for an experienced Analytical Accounting professional who anticipates the changing needs of the business and effectively collaborates across teams to improve outcomes. They should establish effective operational finance processes and robust controls to deliver timely and insightful results. Strong communication...
-
Assurance Director
2 months ago
Boston, United States Marcum LLP Full timeMarcum LLP offers a great career with exceptional benefits. There’s a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading technology, all within an environment that values your contributions and supports...
-
Boston, United States Boston University Full timeThe Quality Assurance Manager will manage the Quality Assurance staff and support NEIDL Leadership with audits and other areas of QA expertise where required or determined to be beneficial to NEIDL operations. The Quality Assurance Manager will report to the Chief Safety Officer and will interact with Principal Investigators whose protocols require good...