Associate Director GCP QA
2 weeks ago
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:
- 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
You should apply if you have:
- 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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Associate Director GCP QA
4 weeks ago
Boston, United States Catalyst Life Sciences Full timeOur 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:Support GCP/GLP studies from a QA perspective(primarily GCP)Conduct GCP & GLP audits(primarily GCP) Support development of Quality...
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Associate Director GCP QA
4 weeks ago
Boston, United States Catalyst Life Sciences Full timeOur 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:Support GCP/GLP studies from a QA perspective(primarily GCP)Conduct GCP & GLP audits(primarily GCP) Support development of Quality...
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Director, GCP Quality
3 hours ago
Boston, United States X4 Life Sciences Full timeX4 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 is a great...
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Director, GCP Quality Assurance
2 weeks ago
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria 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 cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Director, GCP Quality Assurance
2 weeks ago
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria 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 cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Director, GCP Quality Assurance
2 weeks ago
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria 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 cardiovascular disorders where energetic impairment is a fundamental contributor to...
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QA/RA Consultant
1 day ago
Boston, United States Barrington James Full timeQA/RA Consultant required by Barrington James to assist with a pharmaceutical client operating in cell & gene therapies for rare disease, as they get prepared for a PMDA inspection.This will be an initial 6 month contract with travel to the Boston area.You will need to have experience covering both GMP and GCP compliance and have worked with PMDA...
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QA/RA Consultant
1 day ago
Boston, United States Barrington James Full timeQA/RA Consultant required by Barrington James to assist with a pharmaceutical client operating in cell & gene therapies for rare disease, as they get prepared for a PMDA inspection.This will be an initial 6 month contract with travel to the Boston area.You will need to have experience covering both GMP and GCP compliance and have worked with PMDA...
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QA/RA Consultant
2 days ago
Boston, United States Barrington James Full timeQA/RA Consultant required by Barrington James to assist with a pharmaceutical client operating in cell & gene therapies for rare disease, as they get prepared for a PMDA inspection.This will be an initial 6 month contract with travel to the Boston area.You will need to have experience covering both GMP and GCP compliance and have worked with PMDA...
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Associate Director, Quality Assurance
14 hours ago
Boston, United States Rhythm Pharmaceuticals Full timeCompany OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We...
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Associate Director, Quality Assurance
1 day ago
Boston, Massachusetts, United States Rhythm Pharmaceuticals Full timeCompany OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We...
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Associate Director, Quality Assurance
3 days ago
Boston, United States Rhythm Pharmaceuticals Full timeJob DescriptionJob DescriptionCompany OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients...
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Associate Director Clinical Operations
2 weeks ago
Boston, United States Biotech Full timeLocation: 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 therapies.Role Overview: We are seeking a strategic and experienced Associate...
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Associate Director Clinical Operations
3 days ago
Boston, United States Biotech Full timeLocation: 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 therapies.Role Overview: We are seeking a strategic and experienced Associate...
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Associate Director, Clinical Project Lead
2 weeks ago
Boston, United States Alexion Pharmaceuticals, Inc. Full timeAssociate 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 and timeline estimates and operational accountability and management of study...
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Director of Quality Assurance
3 days ago
Boston, United States Walker Cole International Full timeWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA.As the Director of Quality Assurance, you will be responsible for:Leadership of entire QA function including QA Systems, Quality Ops and Validation Participation in internal/external audits and...
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Director of Quality Assurance
3 days ago
Boston, United States Walker Cole International Full timeWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA.As the Director of Quality Assurance, you will be responsible for:Leadership of entire QA function including QA Systems, Quality Ops and Validation Participation in internal/external audits and...
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Director of Quality Assurance
4 days ago
Boston, United States Walker Cole International Full timeWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA.As the Director of Quality Assurance, you will be responsible for:Leadership of entire QA function including QA Systems, Quality Ops and Validation Participation in internal/external audits and...
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Site Director
4 weeks ago
Boston, United States DM Clinical Research Full timeJob DescriptionJob DescriptionSite DirectorThe 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 the sponsor protocol, FDA Regulations and ICH/GCP...
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Director of Quality Assurance
1 day ago
Boston, United States Walker Cole International Full timeWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA. Ready to make your application Please do read through the description at least once before clicking on Apply. As the Director of Quality Assurance, you will be responsible for: Leadership of...