Associate Director GCP QA

2 weeks ago


Boston, United States Catalyst Life Sciences Full time

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


  • Boston, United States Catalyst Life Sciences Full time

    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...


  • Boston, United States Catalyst Life Sciences Full time

    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...

  • Director, GCP Quality

    3 hours ago


    Boston, United States X4 Life Sciences Full time

    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 is a great...


  • Boston, United States Imbria Pharmaceuticals Full time

    Company 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...


  • Boston, United States Imbria Pharmaceuticals Full time

    Company 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...


  • Boston, United States Imbria Pharmaceuticals Full time

    Company 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...

  • QA/RA Consultant

    1 day ago


    Boston, United States Barrington James Full time

    QA/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...

  • QA/RA Consultant

    1 day ago


    Boston, United States Barrington James Full time

    QA/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...

  • QA/RA Consultant

    2 days ago


    Boston, United States Barrington James Full time

    QA/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...


  • Boston, United States Rhythm Pharmaceuticals Full time

    Company 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...


  • Boston, Massachusetts, United States Rhythm Pharmaceuticals Full time

    Company 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...


  • Boston, United States Rhythm Pharmaceuticals Full time

    Job 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...


  • Boston, United States Biotech Full time

    Location: 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...


  • Boston, United States Biotech Full time

    Location: 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...


  • Boston, United States Alexion Pharmaceuticals, Inc. Full time

    Associate 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...


  • Boston, United States Walker Cole International Full time

    Walker 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...


  • Boston, United States Walker Cole International Full time

    Walker 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...


  • Boston, United States Walker Cole International Full time

    Walker 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...

  • Site Director

    4 weeks ago


    Boston, United States DM Clinical Research Full time

    Job 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...


  • Boston, United States Walker Cole International Full time

    Walker 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...