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Kura Oncology
Boston, MA, United States
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the sc
Job Source: Kura OncologyXenon Pharmaceuticals Inc.
Boston, MA, United States
Executive Director, Quality Assurance, GMP Boston, MA, USA Req #267 Monday, May 13, 2024 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 with neurological and p
Job Source: Xenon Pharmaceuticals Inc.Xenon Inc
Boston, MA, United States
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 with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive
Job Source: Xenon IncApex Systems
Boston, MA, United States
Executive Director, Quality Assurance, GMP Executive Director, Quality Assurance, GMP 2034727 Location :Boston, MA (Hybrid) Science: Small Molecule Therapeutics Job Overview: The Executive Director, Quality Assurance, GMP will oversee internal and external GMP quality and leverage extensive quality and manufacturing experience from all clinical
Job Source: Apex SystemsMorphic Therapeutic, Inc.
Waltham, MA, United States
About Morphic Therapeutic Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrdinger, Morphic is advancing its pipeline and discovery activi
Job Source: Morphic Therapeutic, Inc.Cullinan Therapeutics
Cambridge, MA, United States
Summary: We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director/Sr. Director, Global GMP Quality Assurance. The Director/Sr. Director, Global GMG Quality Assurance will act as the Head of GMP QA and has overall responsibility for establishing QMP QA quality objectives, managing the GMP QA team
Job Source: Cullinan TherapeuticsRhythm Pharmaceuticals, Inc
Boston, MA, United States
Company Overview Rhythm 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 and their families.
Job Source: Rhythm Pharmaceuticals, IncRhythm Pharmaceuticals
Boston, MA, United States
Company Overview Rhythm 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 and their families
Job Source: Rhythm PharmaceuticalsBoston, MA, United States
Reporting to the Sr. Director of GMP Quality Assurance. The Sr. Manager/Assoc. Director GMP Quality Assurance will collaborate with the CMC department and external Vendors to ensure oversight and compliance. You will manage GMP activities related to Regulatory Standard Materials, Intermediates, Drug Substances, and Drug Products. Incumbent will continuously improve and maintain Quality Systems related to GMP activities, maintain documentation for compliance with quality and regulatory standards, and will collaborate closely with internal cross-functional teams and management.
Essential Job Functions
Plan and oversee day-to-day GMP activities of the quality function.
Ensure appropriate quality oversight of external Vendors.
Active member of GMP Vendor meetings.
Review and approve Vendor GMP documentation.
Review and approve Vendor and Kura GMP Quality Events.
Review and approve executed batch records for associated Regulatory Standard Materials, Intermediates, Drug Substance and Drug Product and determine final batch disposition.
Support adherence to Vendor Quality Agreements.
Generate quality metrics and compile data for Quality System Reviews.
Participate in Kura GMP sub-teams as the Quality Representative.
Evaluate GMP activities for continuous improvement opportunities to the Kura Quality System.
Provide QA leadership in all matters relating to product quality, disposition and release of materials and finished products.
Provide QA review of CMC related sections of regulatory filings.
Coordinate and manage compliance related activities in preparation for Health Authority inspections and support interactions during Health Authority inspections.
Other Quality Assurance responsibilities as assigned.
Job Requirements
BS/MS degree in a scientific discipline (e.g. chemistry, pharmaceutical sciences or similar).
For Sr. Manager 8+, Associate Director 10+ years of experience in regulated pharmaceutical manufacturing with significant GMP/CMC QA experience. QA oversight of CMO vendors and product disposition experience required.
Demonstrated working knowledge of clinical and commercial manufacturing and quality processes, including US, EU, and ICH regulations and guidelines.
Demonstrated ability to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines.
Proficient in standard business and quality software (e.g. Veeva Quality-Docs, Word, Excel, PowerPoint, SharePoint).
Demonstrates proven track record of quality leadership, communication, and motivation skills with internal and external Vendors.
A good team player with a solid record of collaboration within and across internal teams and vendors. Ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.
Clear, concise writing skills and verbal presentation skills.
Periodic travel to Kura offices, and vendors required. Must be able to travel internationally.
The base range for a Senior Manager is $136,344 - $148,611 and Associate Director is $173,690 - $188,180 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus
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Email Alert for Sr Mgr/Associate Director, GMP Quality Assurance jobs in Boston, MA, United States
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