Associate Director, Quality Assurance
3 weeks ago
The Opportunity:We are seeking a Quality professional to be a cornerstone to a growing and evolving Quality function at Relay Tx. You will partner with your Clinical Development colleagues to oversee several external contract vendors while simultaneously contributing and influencing the build of the Quality Management System as the team evolves along with our pipeline. This is a "wear many hats" role and an exciting opportunity for someone who enjoys the build. At Relay Tx, we take Quality seriously, but we don't take ourselves too seriously. You'll have fun in our collaborative and energetic environment where you'll face new challenges every day. Your Role:You will be front and center, serving as Relay Tx's primary Quality contact for external clinical and patient safety vendors.You will contribute to the development of the GCP/GCLP/GVP Quality Management Systems, conduct risk assessments and identify areas to be audited and potential process improvements.You will review and approve all things GCP/GCLP/GVP; study protocols and manuals, clinical study reports, investigator brochures, informed consent forms, safety management plans, aggregate reports, etc.You will create and execute risk-based clinical trial audit plans and participate in clinical vendor evaluation and qualification.You will create and implement a GCP/GCLP/GVP inspection readiness strategy and plan in collaboration with your Clinical Development colleaguesYou will conduct internal audits and provide audit metrics, audit observations, and develop robust CAPAs for cross functional team and management review.You will develop and execute Quality Agreements with applicable vendors.You will interpret and manage quality investigations associated with GCP/GCLP/GVP operations.You will be proactive, and you will effectively communicate with GCP/GCLP/GVP vendors to address and resolve complex and routine activities while building positive client/vendor relationships, fostering continuous improvement, and adding value to the Clinical Development team.You will be flexible and adaptable. You will eagerly contribute to the development of the Quality Management System even in aspects that extend beyond GCP/GCLP/GVP, including maintaining and reviewing metrics to monitor performance.You will provide Quality Assurance subject matter expertise, leadership, and guidance to external CROs as well as in support of your Relay Clinical Development colleagues.You will provide review of applicable GCP/GCLP/GVP documentation and regulatory submissions.You will contribute significantly to other areas of Quality Assurance as needed as Relay's Quality team grows and the QMS evolves.Competencies for Success: You have a keen attention to detail but can stay focused on the big picture of continual improvement.You are a team-player, flexible and easy to work with in a fast and collaborative environment. You are solution oriented with a customer service approach.You are willing to "roll up your sleeves" and engage in all aspects of the role, big and small.You have great communication skills and don't mind showing them off by traveling to GCP/GCLP/GVP sites, domestic and international, and being the Quality ambassador of Relay Tx. Your Background: Bachelor's degree in a scientific field. Minimum of 10+ years of Quality Assurance/GCP/GCLP/GVP Operations experience in pharmaceutical or biotech industry. In-depth knowledge of GCP/GCLP/GVP and QA principles, practices, and standards; thorough understanding of FDA, MHRA, EMA and ICH quality regulations. #JO1About Relay TherapeuticsRelay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us
-
Director, Quality Assurance
6 days ago
Cambridge, United States Adaptimmune Therapeutics, plc Full timeWe are looking for a Director, Quality Assurance, to join our growing Quality Assurance department to provide quality oversight for our clinical trials, external manufacturing, quality systems, research and development, and regulatory. You will repor Director, Quality Assurance, Continuous Improvement, Quality, Leadership, Clinical, Technology
-
Director, Quality Assurance
2 months ago
Cambridge, United States Adaptimmune Therapeutics Plc Full timeAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our company...
-
Director, Quality Assurance
2 weeks ago
Cambridge, United States Adaptimmune Therapeutics Plc Full timeAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our company...
-
Senior Director, GCP Quality Assurance
1 month ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
-
Senior Director, GCP Quality Assurance
2 weeks ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
-
Senior Director, GCP Quality Assurance
4 weeks ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
-
Senior Director, GCP Quality Assurance
9 hours ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
-
Sr Director Digital System Quality Assurance
2 weeks ago
Cambridge, United States Thermo Fisher Scientific Full timeWork Schedule Other Environmental Conditions Office Job Description When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career...
-
Sr Director Digital System Quality Assurance
3 days ago
Cambridge, United States Thermo Fisher Scientific Full timeWork Schedule Other Environmental Conditions Office Job Description When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals....
-
Cambridge, United States Biogen Full timeThe Associate Director, Decision and Quality Analytics, plays a critical role in supporting the Director by providing strategic leadership and operational oversight focused on quality analytics, and R&D portfolio analytics. Working closely with cross Director, Analytics, Continuous Improvement, Quality, Associate, Leadership, Technology
-
Quality Assurance Manager
4 weeks ago
Cambridge, United States Adaptimmune Therapeutics Plc Full timeAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...
-
Aerospace Quality Assurance Specialist
2 weeks ago
Cambridge, United States Smithsonian Astrophysical Observatory Full time**Description**: **OPENING DATE: June 3, 2024** **CLOSING DATE: June 28, 2024** **TYPE OF POSITION: Trust Indefinite (Non-Federal)** **DIVISION: Central Engineering** **LOCATION: Cambridge, MA** **What are Trust Fund Positions?** Trust Fund positions are unique to the Smithsonian. They are paid for from a variety of sources, including the Smithsonian...
-
Associate Director, Quality Systems Compliance
3 weeks ago
Cambridge, United States Intellia Therapeutics, Inc. Full timeAssociate Director, Quality Systems Compliance page is loaded Associate Director, Quality Systems Compliance Apply locations Cambridge, MA time type Full time posted on Posted 5 Days Ago job requisition id R979 Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe...
-
Cambridge, United States Intellia Therapeutics, Inc. Full timeAssociate Director, Quality Systems Compliance page is loaded Associate Director, Quality Systems Compliance Apply locations Cambridge, MA time type Full time posted on Posted 5 Days Ago job requisition id R979 Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe...
-
Senior Director, Quality Control
9 hours ago
Cambridge, United States Intellia Therapeutics, Inc. Full timeWhy Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Cambridge, United States Biogen Full timeJob Description The Associate Director, Decision and Quality Analytics, plays a critical role in supporting the Director by providing strategic leadership and operational oversight focused on quality analytics, and R&D portfolio analytics. Working closely with cross-functional stakeholders and project teams, the Associate Director contributes to the...
-
Director Quality Operations
3 weeks ago
Cambridge, United States EPM Scientific Full timeQuality Operations Director Key Responsibilities: Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments. Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards. Maintain and oversee a robust quality management system. Collaborate effectively with...
-
Director of Quality Assurance
2 weeks ago
Cambridge, United States Harba Solutions Inc. Full timeResponsibilities Recruit, develop, and motivate staff to ensure effective departmental functions and maintain managerial and specialized skills. Provide coaching and mentoring to staff, focusing on job performance and career development, including training, feedback, rewards, and disciplinary actions. Establish organizational and managerial structures that...
-
Senior Director, Quality Control
1 day ago
Cambridge, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Senior Director, Quality Control
13 hours ago
Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
