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Kura Oncology, Inc.
Boston, 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 con
Job Source: Kura Oncology, Inc.Moderna Therapeutics
Norwood, MA, United States
Sr. Director, Global Engineering page is loaded Sr. Director, Global Engineering Apply locations Norwood, Massachusetts Drug Manufacturing time type Full time posted on Posted 2 Days Ago job requisition id R14728 The Role: Reporting to the SVP Facilities and Engineering, based at our Norwood,
Job Source: Moderna TherapeuticsBioSpace, Inc.
Norwood, MA, United States
Job Details The Role In this technical leadership role, one which has primary responsibility for leading the conceptual and detailed engineering of new manufacturing and R&D facilities worldwide, you will lead a group of subject matters experts across multiple disciplines including Plasmid, mRNA Drug Substance, mRNA Drug Product Manufacturing, Pl
Job Source: BioSpace, Inc.Veeva Systems, Inc.
Boston, MA, United States
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing
Job Source: Veeva Systems, Inc.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 OncologyMorphic 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.Vertex Pharmaceuticals, Inc
Boston, MA, United States
Job Description General Summary: The Sr. Director of Packaging and Labelling Operational Quality will advance compliance oversight for packaging and labelling validation, commercial supply, and product launches in North America and worldwide across the Small Molecule portfolio. The Sr. Director will have a broad role working with stakeholders acros
Job Source: Vertex Pharmaceuticals, IncConfidential
Boston, MA, United States
Global Director About the Company Well-established igaming company Industry Gambling & Casinos Type Privately Held About the Role The Company is seeking a Global Director with a strong background in mathematical testing within the gaming industry. The successful candidate will be responsible for providing strategic leadership in the development a
Job Source: ConfidentialCambridge, 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, and representing GMP Quality on product program teams. This role interprets GMP and GDP regulations, determines quality requirements, and works closely with internal cross-functional teams and external partners to execute quality strategy to support overall product quality. This role fosters a quality culture and mindset for inspection readiness and continuous improvement, through Cullinan and it's global contract manufacturing business partners. The Director Sr. Director regularly provides quality updates and metrics in department, project, and quality management review meetings. The Director/Sr. Director, Global GMP Quality has multiple direct reports, is a member of the Quality Assurance Leadership Team (QALT) and reports to the Vice President, Quality Assurance.
Position Responsibilities:
Provide Quality leadership on planning and execution of the GMP QA Strategy
Ensure and deliver Quality and Compliance oversight for manufacturing of biologic and investigational cell-based products..
Disposition of batches manufactured by Cullinan Therapeutics contract manufacturer(s).
Provide guidance, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and standards to direct reports and cross-functional internal and external teams.
Lead, manage, and execute ongoing maintenance and continuous improvements of GMP QA quality systems, including but not limited to, compliance and follow through to completion of audits, documents, deviations, CAPA, change control, complaints, management review, validation, and data integrity.
Maintain and improve GMP QA quality standards across all areas through quality team leadership and cross-functional collaboration.
Prepare and present quality related updates, metrics, and trends at internal project, quality management review, and partner meetings.
Develop, review and/or approve GMP documentation, including but not limited to Specifications, Standard Operating Procedures, Validation Protocols and Reports, Deviations, CAPAs and Change Controls.
Maintain a prepared state of inspection readiness through training, leadership and collaboration to support CMOs during Agency PAIs.
Lead the Quality representation for Tech Transfer of investigational products, including active input and decision making related to transfer strategy, protocol development, transfer execution, and final approval.
Determine and ensure proper qualification, quality oversight and management of CMOs
Candidate Requirements:
Excellent written and oral communication skills
Excellent collaboration, negotiation, and team leadership skills
Team goal setting and planning to achieve results through effective staff management through a positive, engaging, and inspiring management style.
Effective application of analytical and investigational techniques to identify root cause and problem solve
Advanced knowledge of aseptic cell processing, testing, and release requirements
Support company growth through effective staff development
Internal/External Quality Operations management balancing business needs and compliance standards
Ever focused on development of business process optimizations
Ability to prioritize and manage multiple projects within aggressive production schedules
B.S. / M.S. in microbiology, biological, life sciences, pharmaceutical sciences, or related discipline with at least 10 years QA management experience and at least 15 years related experience.
Advanced knowledge and experience in aseptic cell processing quality best practices and regulatory requirements, including 21 CFR 210/211, 600s, and 1271.
Prior experience interfacing with and managing inspections performed by FDA and other regulatory bodies.
Expert level knowledge of GMP regulations and FDA CBER requirements, Guidance documents, and industry best practices.
Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, FDA CBER/EMA, and ICH.
Knowledge of current best practices and industry standards for tissue sourcing, biologics manufacturing; experience with advanced biologic therapies and aseptic techniques.
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Email Alert for Director/Sr. Director, Global GMP QA jobs in Cambridge, MA, United States
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