Senior Director of Quality Assurance

11 hours ago


Cambridge, Massachusetts, United States Jobot Full time
Job Summary

We are seeking a highly experienced Senior Director of Quality Assurance to provide quality oversight of our clinical development programs and manufacturing. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance in our GMP suppliers.

Key Responsibilities

* Provide quality support and guidance for our CMC programs
* Ensure that GMP quality documentation is securely archived and retrievable
* Investigate, evaluate, and manage potential quality impact of product complaints and temperature excursions
* Ensure inspection readiness at our GMP suppliers
* Provide GMP quality review and feedback on regulatory application submissions and agency responses/information requests

Requirements

* Bachelor's degree in a scientific field
* 10+ years' experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting
* Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers
* Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously

What We Offer

* Approximately 10-20% travel (domestic and international)
* Opportunity to work with a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases

  • Cambridge, Massachusetts, United States Jobot Full time

    Job Title: Senior Director, Quality AssurancePublicly Traded + Equity + Annual Bonus + HybridWe are a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.Why Choose Us?Competitive SalaryAnnual BonusEquityESPP401k ProgramMedical/Vision/DentalHybrid ScheduleJob Description:We are seeking a Senior Director of...


  • Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time

    Job Title: Senior Director, Quality ControlBeam Therapeutics Inc. is seeking a highly experienced Senior Director, Quality Control to join our team in Cambridge, Massachusetts. As a key member of our Quality Control organization, you will be responsible for leading the quality control organization at our Massachusetts facility and providing strategic...


  • Cambridge, Massachusetts, United States Jobot Full time

    Job DescriptionWe are a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.As a Senior Director of Quality Assurance, you will provide quality oversight of our clinical development programs and manufacturing.Responsibilities:Provide quality support and guidance for our CMC programsPlan, conduct or facilitate...


  • Cambridge, Massachusetts, United States Jobot Full time

    Job OverviewWe are seeking a seasoned Senior Director of Quality Assurance to provide strategic quality oversight of our clinical development programs and manufacturing operations.This is a hybrid position requiring 3 days per week on-site at our facility.Key ResponsibilitiesProvide quality support and guidance for our CMC programsPlan, conduct, or...


  • Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time

    Job Title: Senior Director, Quality ControlBeam Therapeutics Inc. is seeking a highly experienced Senior Director of Quality Control to join our team in Cambridge, Massachusetts.Job Summary:The Senior Director of Quality Control will be responsible for leading the quality control organization at Beam's Massachusetts facility. This role will oversee the QC...


  • Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Job Title: Incoming Materials, Senior QA SpecialistProclinical is seeking an experienced Incoming Materials, Senior QA Specialist to join our team in Cambridge, MA.Job Summary:The Incoming Materials, Senior QA Specialist will play a critical role in ensuring the quality and compliance of materials procured by our organization. This position requires a strong...


  • Cambridge, Massachusetts, United States Philips Full time

    Job Title: Director, Design and Software Quality AssuranceAt Philips, we are seeking a highly skilled and experienced Director, Design and Software Quality Assurance to join our team. As a key member of our organization, you will be responsible for ensuring all functions of Design Assurance & Software Quality Engineering are in compliance with all applicable...


  • Cambridge, Massachusetts, United States PSG Global Solutions Careers Full time

    Job Title: Senior Quality Control AssociateAt PSG Global Solutions Careers, we're seeking a highly skilled Senior Quality Control Associate to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the quality and compliance of our raw materials.About the Role:We're looking for a seasoned professional...


  • Cambridge, Massachusetts, United States eGenesis Bio Full time

    Job Title: Senior Manager, Quality Assurance Job Summary: At eGenesis Bio, we are seeking a highly skilled Senior Manager, Quality Assurance to oversee our GMP cloning operations and Supplier Management Program. This is a critical role that requires strong leadership, technical expertise, and excellent communication skills. Key Responsibilities: *...


  • Cambridge, Massachusetts, United States eGenesis Bio Full time

    Job Title: Senior Manager, Quality AssuranceAt eGenesis Bio, we are seeking a highly skilled and experienced Senior Manager, Quality Assurance to join our team. This is a critical role that will oversee the GMP cloning operations and Supplier Management Program to ensure compliance with regulatory requirements.Key Responsibilities:Develop, implement, and...


  • Cambridge, Massachusetts, United States Mass General Brigham Full time

    Job Title: Senior Registered Nurse - Quality Assurance SpecialistMass General Brigham is seeking a highly skilled Senior Registered Nurse to join our Quality Assurance team. As a Senior Registered Nurse - Quality Assurance Specialist, you will play a critical role in ensuring the highest quality of care for our patients.Job Summary:The Senior Registered...


  • Cambridge, Massachusetts, United States eGenesis Bio Full time

    Job Title: Senior Manager, Quality AssuranceeGenesis Bio is seeking a highly skilled Senior Manager, Quality Assurance to oversee the GMP cloning operations and Supplier Management Program. This role will be responsible for ensuring compliance to GMP standards of vendors that are part of the Supplier Management Program.Key Responsibilities:Developing,...


  • Cambridge, Massachusetts, United States Mass General Brigham Full time

    Job Title: Senior Registered Nurse - Quality Assurance SpecialistMass General Brigham is seeking a highly skilled and experienced Registered Nurse to join our team as a Senior Registered Nurse - Quality Assurance Specialist. This role will be responsible for coordinating clinical quality assurance activities, including the development and review of training...


  • Cambridge, Massachusetts, United States Mass General Brigham Full time

    Job Title: Senior Registered Nurse - Quality Assurance SpecialistMass General Brigham is seeking a highly skilled and experienced Registered Nurse to join our team as a Senior Registered Nurse - Quality Assurance Specialist. This role will be responsible for ensuring the highest level of quality care is provided to our patients by conducting audits,...


  • Cambridge, Massachusetts, United States Mass General Brigham Full time

    Job Title: Senior Registered Nurse - Quality Assurance SpecialistMass General Brigham is seeking a highly skilled and experienced Registered Nurse to join our team as a Senior Registered Nurse - Quality Assurance Specialist. This role will be responsible for coordinating clinical quality assurance activities, including the development and review of training...


  • Cambridge, Massachusetts, United States Korro Bio, Inc. Full time

    About Korro Bio, Inc.Korro Bio, Inc. is a biopharmaceutical company pioneering the development of genetic medicines for rare and prevalent diseases using its proprietary RNA editing platform. Our mission is to harness the body's natural RNA editing process to deliver precise and transient single base edits, expanding the reach of genetic medicines and...


  • Cambridge, Massachusetts, United States PSG Global Solutions Careers Full time

    The OpportunityWe're seeking a highly skilled Senior Quality Control Associate to join our team in the Pharmaceuticals and Medical Products industry.Collaborate with vendors, internal quality control, process sciences, manufacturing, and quality assurance departments to ensure raw material specifications meet company and regulatory expectations.Develop and...


  • Cambridge, Massachusetts, United States Third Rock Ventures Full time

    Senior Manager/Associate Director, Quality ControlThird Rock Ventures is seeking a Senior Manager/Associate Director, Quality Control to lead and independently perform technical and operational aspects of QC activities for antibody and fusion protein products across the company's pipeline. The ideal candidate will have a strong background in analytical...


  • Cambridge, Massachusetts, United States Moderna Therapeutics Full time

    About the RoleThe Senior Manager of Clinical Quality Assurance will play a critical role in promoting compliance to Good Clinical Practice (GCP) regulations by providing Clinical and Research Development teams with compliance guidance and support related to GCP global regulations and guidelines.Key ResponsibilitiesDevelop and implement clinical quality...


  • Cambridge, Massachusetts, United States The Fountain Group Full time

    Job Summary: We are seeking a highly skilled Senior Quality Assurance Manager to join our team at The Fountain Group. The ideal candidate will have a strong background in pharmaceutical quality assurance and regulatory compliance.Key Responsibilities:Review and approve regulated study reports from third-party vendorsSupport M&A integration activities and...