- 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 Quality Assurance
3 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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Director, GCP Quality Assurance
5 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 cells ability to produce energy in cardiova ...
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Associate Director GCP QA
1 day ago
Catalyst Life Sciences Boston, United StatesOur 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. · For a complete understanding of this opportunity, and what will be r ...
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Director, GCP Quality Assurance
1 day 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 cardiov ...
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GCP Biomarker Quality Associate Director
5 days ago
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: · The Associate Director, Biomarker Operational Quality will provide biomarker quality leadership and oversight across GxPs-related to research and development, implementation into clinical trials and potential commercialization of clinical biom ...
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Director of Information Technology
5 days ago
Franklin Fitch Boston, United StatesIT Infrastructure Director | Boston, MA (Hybrid) | $185,000-$215, % Bonus · A leading biotech firm is seeking an experienced IT Infrastructure Director who will be responsible for managing a 12-person IT team as well as taking ownership over their IT infrastructure across server ...
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Third Rock Ventures Boston, United StatesAs our clinical development portfolio evolves, Tango has an exciting new opportunity to join our team as a Director/Senior Director, Clinical Pharmacology. Reporting to our SVP, Pharmaceutical Sciences, you will be responsible for the design and implementation of clinical pharmac ...
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Director Clinical Operations
5 days ago
EPM Scientific Boston, United StatesSalary: $200,000-$220,000 · Director Clinical Operations · Boston, MA (Hybrid) · Job Description · A pioneering Biotech in the heart of Boston, dedicated to revolutionizing autoimmune disease treatment is looking to bring on a Director of Clinical Operations. By leveraging cuttin ...
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Senior Clinical Scientist
1 week ago
Verve Therapeutics Inc Boston, United StatesThe Position · Verve is seeking an experienced Senior Clinical Scientist to join our team as we continue to advance gene editing medicines for cardiovascular disease into clinical development. In this position, you will be an integral part of the clinical development team support ...
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Tango Therapeutics 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 p ...
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The Elle Group Boston, 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 · Fi ...
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Senior Clinical Trial Manager
5 days ago
Third Rock Ventures Boston, United StatesAs a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximall ...
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Associate Director Clinical Operations
3 days ago
Biotech Boston, United StatesLocation: Boston, MA (Relocation package available) · Company Overview: Join a pioneering oncology biotech company based in the vibrant Boston biotech community. Their mission is to revolutionize cancer treatment through innovative research and the development of cutting-edge the ...
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Boston Childrens Hospital Boston, United StatesJob Posting Description · *** A cover letter is required at point of application*** · The Department of Otolaryngology and Communication Enhancement is a large interdisciplinary team seeking a full-time Clinical Research Manager I to manage the daily operations of the department' ...
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Associate Director, Clinical Project Lead
5 days ago
Alexion Pharmaceuticals, Inc. Boston, United StatesAssociate Director, Clinical Project Lead · This is what you will do: · The Associate Director, Clinical Project Lead is responsible to lead the Cross-Functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility and budget ...
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Senior Manager, Clinical Trial Lead
5 days ago
Olema Pharmaceuticals Boston, United StatesAbout the Role >>> Senior Manager, Clinical Trial Lead · We are looking for a Senior Manager, Clinical Trial Lead (CTL) for our growing Clinical Operations team. The Senior Manager, Clinical Trial Lead is responsible for the day-to-day management of clinical trials, vendors, and ...
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Frontier Medicines Boston, United States· Join us as the Senior Manager/Associate Director of Quality Assurance at Frontier, where precision meets purpose. In this pivotal role, you'll oversee GCP/GLP Quality Assurance activities, ensuring meticulous adherence to standards that drive our growth objectives forward. Bey ...
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Senior Clinical Data Manager
5 days ago
X4 Pharmaceuticals, Inc. Boston, United StatesSenior Clinical Data Manager · Reporting to: Senior Director, Clinical Data Management · Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite yo ...
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Director/Sr. Director, Clinical Science
5 days ago
Scorpion Therapeutics Boston, United StatesScorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most ad ...
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Cloud Engineer
6 days ago
Saxon Global Boston, United StatesTitle : Cloud Engineer · Company : Life Sciences · Location : Waltham MA · Location Details: Onsite 2-3 days/week (Tuesday & Thursday is a hard must) · Duration: 6 months · Visa : No H1 · Rate: $75/hr. on C2C · Must be strong with Azure - prefer Certifications. · Strong w ...
Associate Director GCP QA - Boston, 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: