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Meet Recruitment Limited
Cambridge, MA, United States
We are partnering with a Massachusetts based Biotech to help them add a Manager of GCP Quality Assurance who will provide expertise and guidance on Good Clinical Practice (GCP), applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation. Responsibilities Provide expe
Job Source: Meet Recruitment LimitedAura Biosciences
Boston, MA, United States
Job Description Job Description Salary: About Aura Biosciences Aura Biosciences is a clinical- stage biotechnology company developing precision immunotherapies to treat solid tumors designed to preserve the function of the organ with cancer. Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with primary
Job Source: Aura BiosciencesRelay Therapeutics
Cambridge, MA, United States
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 a
Job Source: Relay TherapeuticsVertex Pharmaceuticals
Boston, MA, United States
GCP Biomarker Quality Associate Director page is loaded GCP Biomarker Quality Associate Director Apply locations Boston, MA time type Full time posted on Posted 5 Days Ago job requisition id REQ-21957 Job Description General Summary: The Associate Director, Biomarker Operational Quality will provide biomarker q
Job Source: Vertex PharmaceuticalsKura 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.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 TherapeuticsX4 Life Sciences
Boston, MA, United States
X4 Life Sciences are working with one of Boston's leading biotechs focusing on rare diseases across both small molecules & gene therapy programs. They're looking for a Director of GCP QA to facilitate their continued growth. This role is responsible for overseeing GCP activities and leading event investigations across a range of modalities. This i
Job Source: X4 Life SciencesPresidio
Woburn, MA, United States
Description SEIZE THE OPPORTUNITY TO BE A PART OF SOMETHING GREAT! Presidio is on the leading edge of a technology-driven movement to transform the way business is done, for our customers and our customers' customers. Joining Presidio means immersing yourself in a culture of self-starters, collaborators and innovators who make real, lasting change
Job Source: PresidioBoston, MA, United States
Meet the Client:
We are partnering with a Massachusetts-based Biotech to help them add a Manager of GCP Quality Assurance who will provide expertise and guidance on Good Clinical Practice (GCP), and applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation.
Responsibilities
Provide expertise in GCP, compliance interpretation, consultation, training, and recommendations to clinical development functions and program teams
Lead investigations into significant quality issues, scientific misconduct, and suspected serious breaches of GCP or GLP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate. Manage deviations and CAPAs through the completion
Identify and mitigate GCP activities and process improvement initiatives as requested by management
Work closely with Quality Assurance Head to ensure alignment and compliance with their Quality Systems
Provide risk identification/mitigation support for potential or identified quality issues
Appropriately escalate any quality/compliance issues to relevant leadership
Perform a quality assurance review of documents and data intended for regulatory submission
Qualifications
Bachelor’s degree in a scientific discipline is required. Advanced degree preferred.
7+ years of clinical trial experience in a pharmaceutical, biotech, hospital setting, or CRO is required with at least 5 years managing clinical trials.
Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development
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Email Alert for Sr Manager/Associate Director, GCP QA jobs in Boston, MA, United States
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