- Support GCP/GLP studies from a QA perspective(primarily GCP)
- Conduct GCP & GLP audits(primarily GCP)
- Support development of Quality Management Systems
- Ensure safety & PV programs are mature and compliant
- Assist in navigating vendor management issues
- 8+ years of GCP/GLP QA experience
- Experience with preparing for approval audits
- Experience developing QMS
- Strong vendor management experience
- Experience supporting GCP/GLP audits
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Director, Gcp Operational Quality
6 days ago
Vertex Pharmaceuticals Boston, United StatesJob Description · GENERAL: · The Director, GCP Compliance is responsible for the escalation and management and compliance activities in support Quality Issues Management and other activities within RDQA. This role will act as a lead for GCP related events and escalation of these ...
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Director, Quality GCP
2 weeks ago
Entrada Therapeutics Boston, United States Full timeThe Organization · What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. · O ...
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Director, GCP Quality Assurance
2 days ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...
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Senior Director Clinical Quality, GCP
3 days ago
Merus Cambridge, United StatesSenior Director Clinical Quality, GCP · Application Deadline: 21 June 2024 · Department: Clinical Operations · Employment Type: Full Time · Location: Cambridge, MA · Description · We are on the lookout for an experienced Clinical Quality Director, GCP. · In this role you wi ...
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Senior Director, GCP Quality Assurance
4 days ago
Scholar Rock Cambridge, United StatesScholar 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 ...
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Vertex Pharmaceuticals Boston, United StatesJob Description · General Summary: · Reporting to the Director of Inspection Excellence within Clinical Quality Management, the Clinical Quality Management Associate Director will support the management and operational oversight of Quality Events and is responsible for leading Qu ...
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Associate Director, Clinical Demand Planning
6 days ago
Alexion Pharmaceuticals,Inc. Boston, United StatesLocation: Boston, United States; New Haven, United States · Job reference: R-199179 · Date posted: 05/08/2024 · **This is what you will do**: · The Associate Director, Global Clinical Demand Planning is responsible for the support and evolution of a robust clinical demand plannin ...
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Associate Director, Laboratory Information
14 hours ago
AstraZeneca Waltham, United States**Associate Director, Laboratory Information Management System (LIMS) Product Owner** · **Gaithersburg, MD or Waltham, MA** · Join our Translational Medicine and Cancer Biomarker Development (TM/CBD) teams within Early Oncology at AstraZeneca, where we strive to transform oncolog ...
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Site Director
1 week ago
DM Clinical Research Boston, MA, United StatesSite Director · The Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality research is conducted at assigned investigative sites in accordance with t ...
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argenx SE Boston, MA, United StatesClinical and Pharmacovigilance Quality USA Lead (Director) page is loaded · Clinical and Pharmacovigilance Quality USA Lead (Director) · Apply locations Boston time type Full time posted on Posted 2 Days Ago job requisition id REQ-2626 To further strengthen our Quality team, we ...
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Kura Oncology, Inc. Boston, MA, United StatesESSENTIAL JOB FUNCTIONS: · Reporting to the Head of Quality Assurance, the Director/Sr. Director, Clinical Quality Assurance (CQA) is responsible for the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive en ...
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Director, GxP Quality
1 week ago
Third Rock Ventures Boston, MA, United StatesCompany Overview · Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. · Using an approach that starts and ends with patients, Tango leverages the genetic ...
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Director of Travel I
2 weeks ago
Third Rock Ventures Boston, MA, United StatesTango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. · Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthe ...
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Kura Oncology Boston, MA, United StatesAre 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 ...
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The Elle Group Boston, MA, United StatesThe Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management. · - MD degree and board certification preferred · ...
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Site Director
4 days ago
DM Clinical Research Boston, United StatesJob Description · Job DescriptionSite Director · The Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality research is conducted at assigned investigat ...
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Associate Director Clinical Operations
1 week ago
Clinical Dynamix Boston, United StatesAssociate Director, Early Development (Clinical Operations) · The Associate Director, Early Development Clinical Operations is responsible for leading projects to support the execution of clinical studies aligned with the clinical development plan according to the agreed upon tim ...
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tapwage Boston, United States Full timeJob Description · General Summary: · The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials in Vertex' Nephrology programs, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution an ...
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Associate Director/Director, Clinical Compliance
2 weeks ago
Verve Therapeutics, Inc. Boston, MA, United StatesJob Description · Job Description · The Company · Verve Therapeutics is a biotechnology company created with a singular focus: to protect the world from heart disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, the company aim ...
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Director Clinical Operations
5 days ago
Green Key Resources Boston, United StatesJoin our team as a Director Clinical Operations where you'll play a pivotal role in orchestrating the planning, execution, and oversight of clinical studies. Your responsibilities include managing day-to-day operations, collaborating with Clinical Research Organizations (CROs), c ...
Associate Director GCP QA - Boston, MA, United States - Catalyst Life Sciences
Description
Our client is currently seeking an Associate Director of GCP QA to join their growing quality team. This is a hybrid position supporting a well-funded clinical stage Biotech client in the Greater Boston area.
Day to day you will:
You should apply if you have: