Current jobs related to Associate Director GCP QA - Boston - Catalyst Life Sciences

  • Director, RDQA, GCP Operational Quality, CGT

    2 weeks ago

    Boston, United States Vertex Pharmaceuticals Incorporated Full time

    Director, RDQA, GCP Operational Quality, CGTThe Director of GCP Operational Quality performs advanced GCP quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies,...

  • Director, RDQA, GCP Operational Quality, CGT

    2 weeks ago

    Boston, United States Vertex Pharmaceuticals Incorporated Full time

    Director, RDQA, GCP Operational Quality, CGTThe Director of GCP Operational Quality performs advanced GCP quality assurance oversight and management activities of clinical trial operations to ensure Vertex trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies,...

  • Director, Quality GCP

    2 months ago

    Boston, United States Entrada Therapeutics Full time

    The 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. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the...

  • Director, Quality GCP

    3 weeks ago

    Boston, United States Entrada Therapeutics Full time

    The 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. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the...

  • Director, Quality GCP

    1 month ago

    Boston, United States Entrada Therapeutics Full time

    The 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. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the...

  • Director, GCP Operational Quality

    2 weeks ago

    Boston, United States Vertex Pharmaceuticals Incorporated Full time

    Job DescriptionGENERAL POSITION SUMMARY:The Director, GCP Compliance is responsible for the escalation and management of compliance activities in support of Quality Issues Management and other activities within RDQA. This role will act as a lead for GCP related events and escalation of these events. This individual will work closely with Quality Leads, Study...

  • Senior Director, RDQA, Operational Quality, Medical Device and Combination Therapies

    2 months ago

    Boston, United States Vertex Full time

    Job DescriptionGeneral position summary: The Sr. Director, RDQA Medical Device and Combination therapies will ensure operational delivery and execution and provide strategic direction and oversight of the device and combination therapy programs within Research and Development QA (RDQA) from the (pre)clinical phases of the product lifecycle through to...

  • Head, GCP/GLP Quality Assurance

    1 month ago

    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...

  • Associate Director, Clinical Data Management

    1 week ago

    boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    1 week ago

    boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    3 months ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    3 months ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, CMC Compliance

    3 weeks ago

    Boston, United States Vertex Pharmaceuticals Incorporated Full time

    Job DescriptionGeneral Summary:The Associate Director, CMC Compliance is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics,...

  • Associate Director, CMC Compliance

    3 weeks ago

    Boston, United States Vertex Pharmaceuticals Incorporated Full time

    Job Description General Summary: The Associate Director, CMC Compliance is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and analytics,...

  • Director QA Operations, Cell& Gene, Mfg Systems

    2 weeks ago

    Boston, United States Vertex Pharmaceuticals Incorporated Full time

    Job DescriptionDirector of Quality Cell & Gene, Manufacturing Systems is accountable for ensuring Operational Systems related improvements and projects are planned, prioritized, and executed in a systematic manner. The role is accountable for leading/supporting continuous improvements of quality operations processes, development of digital roadmaps including...

  • Director Quality CMC Development

    2 weeks ago

    Boston, United States Cpl Healthcare Full time

    Director of Quality CMC Development - East Coast based remoteThis role offers the flexibility to work remotely from locations within the U.S/Canada, with a preference for Eastern Time Zone working hours to collaborate with EU teams.Travelis required.Position Overview:Cpl Life Sciences is looking for a Director of Quality CMC Development (Product...

  • Associate Director, Vendor Quality Management

    4 weeks ago

    Boston, United States Vertex Full time

    Job DescriptionGeneral Summary:The Associate Director, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and...

  • Associate Director of Account Management

    4 months ago

    Boston, United States Mondo Full time

    Job DescriptionJob DescriptionApply now: Associate Director, Account Management location is Boston, MA. The start date is ASAP for this full-time permanent position Job Title: Associate Director, Account Management Location-Type: Boston, MA Onsite 2-4x a month Start Date Is: ASAP Duration: FTE Permanent Compensation Range: $120-145K Job Description: Must...

  • Associate Director, Quality Control

    4 weeks ago

    Boston, United States PepGen Full time

    Job DescriptionJob DescriptionAssociate Director, Quality Control  Reporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen’s pipeline. In addition, this position will be required to actively...

  • Associate Director, Quality Control

    4 weeks ago

    Boston, United States PepGen Full time

    Job DescriptionJob DescriptionAssociate Director, Quality Control  Reporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen’s pipeline. In addition, this position will be required to actively...

Associate Director GCP QA

4 months 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.



For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on.

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