Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
Hillevax
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 mil
Job Source: HillevaxHilleVax, Inc.
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 mil
Job Source: HilleVax, Inc.FogPharma
Cambridge, MA, United States
Why join us? FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by
Job Source: FogPharmaKula Bio, Inc
Natick, MA, United States
Job Type Full-time Description Kula Bio is a leader in sustainable nitrogen solutions, helping farmers improve crop yield and reduce environmental impact. We are producing a cost-competitive biofertilizer that boosts a naturally occurring process to deposit meaningful amounts of nitrogen in the soil. We are seeking a hands- on Analytical Bio/Che
Job Source: Kula Bio, IncBlackwomenintech
Boston, MA, United States
Job#: 2019758 Job Description: Director, QualitySystems (eQMS Veeva) 2019758 Location: Boston,MA(Hybrid / Onsite) Therapeutic Area: Small molecule Pharma Job Overview: The role requires leading the development, design, and maintenance of the Quality System to ensure efficiency, effectiveness, and compliance with quality regulations and standar
Job Source: BlackwomenintechLantheus Medical Imaging Inc
Billerica, MA, United States
Default Location 331 Treble Cove Rd Billerica, Town of, MA 01862, USA Default Location 331 Treble Cove Rd Billerica, Town of, MA 01862, USA Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has he
Job Source: Lantheus Medical Imaging IncApex Systems
Boston, MA, United States
Director, Quality Management Systems 2019758 Location: Boston,MA(Hybrid / Onsite) Therapeutic Area: Small molecule Pharma Job Overview: The role requires leading the development, design, and maintenance of the Quality Management System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, reporting to the He
Job Source: Apex SystemsXenon Pharmaceuticals Inc.
Boston, MA, United States
Associate Director/Director, Quality, Regulatory & Supply Chain Information Systems Boston, MA, USA Req #256 Who We Are: Who 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 wit
Job Source: Xenon Pharmaceuticals Inc.Boston, MA, United States
Associate Director – Quality Systems
Location: Boston, MA
Role Summary:
Monte Rosa Therapeutics is seeking a passionate Associate Director/Director of Quality Systems is responsible for maintaining and maturing Monte Rosa Tx’s GxP Quality System, which includes, but is not limited to documentation, training, supplier quality, internal audits, product complaints, risk management, change controls, deviations and CAPAs. The Quality Systems leader will also provide technical quality oversight for the qualification and validation of facilities, systems and equipment, as well as process validation. Responsible for oversight of phase-appropriate Monte Rosa Quality System (QS) activities, including Document Management and Training, Quality Event Management (Deviations, Change Control, CAPAs, Investigations), Metrics, Risk Management, Product Complaints/Recalls, Audit and Supplier Management.
Supporting quality systems in both Boston and Basel locations.
Key Responsibilities:
•Manage and support the document creation and lifecycle process, including periodic reviews.
•Ensure GxP training and employee qualification is properly managed and compliant. Provide GxP and GxP system training where applicable.
•Manage and maintain the audit schedule and auditor qualifications. Ensure audit observations are communicated, tracked and remediated.
•Provide a risk-based oversight of vendor selection, qualification and management.
•Support, manage the quality event/issue identification, assessment, resolution, and effectiveness confirmation as well as educate/support record owners.
•Support and participate in inspection readiness activities for regulatory inspections – both internally and at sites (GCP and GMP).
•Facilitate the Quality Management Reviews including quality metrics and key quality topics for leadership
•Support Computer System Validation quality efforts as applicable for GxP Systems.This also includes being an administrator for electronic Quality Systems (i.e., DMS, LMS, QMS) as applicable.
•Interface with internal departments and external vendors on a variety of technical/quality subjects.
Skills & Qualifications
•BS Degree in Chemistry, Pharmacy, Biology or a related life science, or a combination of a BS Degree with relevant Quality and Technical experience.
•Minimum of 12 years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations.
•Knowledge and experience of clinical and commercial systems supporting compliance with US and global regulations (FDA, EMA, ICH, etc.). GLP experience a plus.
•Able to provide solution-minded approach and flexibility to emerging challenges.
•Able to appropriately balance priorities plus multi-task against competing priorities.
•Proven experience with the desire, and ability to work in a fast-paced, matrixed, start-up environment.
•Strong collaboration and team-working, communication, and organizational skills required.
•Strong problem-solving, critical thinking, and analytical skills necessary
•Ability to travel up to 10%.
Interested Candidates may forward CV and Cover Letter letting us know your area of interest please forward to [email protected]
Monte Rosa Therapeutics (MRT) is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to identify degradable protein targets and rationally design MGDs with unprecedented selectivity. The QuEEN discovery engine enables access to a wide-ranging and differentiated target space of well-validated biology across multiple therapeutic areas. Monte Rosa has developed the industry’s leading pipeline of MGDs, which spans oncology, autoimmune and inflammatory disease and beyond, and has a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug.
#J-18808-Ljbffr
Email Alert for Associate Director – Quality Systems jobs in Boston, MA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.