Director of Biologics Quality Assurance

3 weeks ago


Cambridge, Massachusetts, United States Jobot Full time
Job Summary:

We are seeking an experienced Senior Director of Quality Assurance (GMP) 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 operations.

About Us:
We are a publicly traded biotechnology company developing innovative treatments for chronic dermatological diseases. Our mission is to deliver high-quality products that improve patient outcomes while driving business growth.

Responsibilities:
- Provide quality support and guidance for our CMC programs
- Ensure inspection readiness at our GMP suppliers
- Investigate, evaluate, and manage potential quality impact of product complaints and temperature excursions
- Collaborate with cross-functional teams to drive continuous improvement of quality and compliance practices

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

What We Offer:
- Competitive salary: $180,000 - $220,000 per annum
- Hybrid work arrangement with 3 days per week on-site
- Opportunities for professional growth and development

How to Apply:
Please submit your resume and cover letter for consideration.

  • Cambridge, Massachusetts, United States Jobot Full time

    Job OverviewWe are a publicly traded biotechnology company developing innovative solutions for chronic dermatological diseases.Salary and Benefits$240,000 - $270,000 per year. Competitive salary, annual bonus, equity, ESPP, 401k program, medical/vision/dental benefits, and hybrid schedule.Job DescriptionWe seek a Senior Director of Quality Assurance (GMP) to...


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

    Role Overview:We are seeking a highly experienced Senior Manager/Associate Director, Quality Control to lead our QC activities for antibody and fusion protein products across our pipeline.About the Job:In this role, you will develop strategies and execute QC activities for all pipeline programs. This includes in-process/release/stability testing,...


  • Cambridge, Massachusetts, United States Jobot Full time

    Job OverviewThis Senior Director of Quality Assurance (GMP) role is available at a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.Compensation:$240,000 - $270,000 per yearResponsibilitiesProvide quality support and guidance for CMC programsPlan, conduct or facilitate supplier qualification audits and site...


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

    About the RoleThis is an exciting opportunity for a seasoned quality professional to join our team as Director of Quality Assurance Management. As a key member of our operations team, you will be responsible for establishing and maintaining appropriate development phase GMP/GLP compliance. Your expertise in material/product disposition activities, testing...


  • Cambridge, Massachusetts, United States Jobot Full time

    Job SummaryWe are a publicly traded biotechnology company developing innovative treatments for chronic dermatological diseases. Our team is seeking a seasoned Senior Director of Quality Assurance (GMP) to provide expert guidance on quality oversight for our clinical development programs and manufacturing processes.The ideal candidate will have extensive...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Welcome to Takeda Pharmaceutical, a world-leading biopharmaceutical company dedicated to improving lives through innovative medicines.About Us:We strive to create a diverse and inclusive work environment that fosters collaboration, creativity, and growth. Our commitment to equality and fairness has earned us recognition as an employer of choice.Job...


  • Cambridge, Massachusetts, United States Jobot Full time

    Jobot is a publicly traded biotechnology company developing innovative solutions to treat chronic dermatological diseases. We are seeking an experienced Senior Director, Quality Assurance to provide quality oversight of our clinical development programs and manufacturing.About the RoleProvide quality support and guidance for our CMC programs, ensuring...


  • Cambridge, Massachusetts, United States Voyager Therapeutics Full time

    Join Our TeamVoyager Therapeutics is a rapidly growing biotech company looking for a Quality Assurance Specialist to join our team. This is an exciting opportunity to be part of a dynamic organization that is making a difference in the field of gene therapy.The successful candidate will have a strong background in quality assurance and compliance, with a...


  • Cambridge, Massachusetts, United States Jobot Full time

    We are seeking a seasoned professional to fill the role of Senior Director of Quality Assurance (GMP) and lead our quality assurance efforts.The estimated salary for this position is approximately $180,000 per year, reflecting the industry standard and the specific requirements of this role.Your key responsibilities will include:Developing and implementing...


  • Cambridge, Massachusetts, United States Vericel Corporation Full time

    Job OverviewWe are seeking a highly skilled Senior Quality Control Analyst to join our team at Vericel Corporation. Based in Cambridge, MA, this role offers an exciting opportunity to contribute to a commercial stage company with a strong portfolio of advanced cell therapies and specialty biologics.


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleAt Takeda Pharmaceutical, we are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status,...


  • Cambridge, Massachusetts, United States Jobot Full time

    About the RoleWe are seeking a highly experienced GMP Quality Director to join our team. As a key member of our quality leadership group, you will provide strategic direction and oversight for our quality assurance programs, ensuring compliance with regulatory requirements and industry standards. Your primary focus will be on supporting the development and...


  • Cambridge, Massachusetts, United States Jobot Full time

    About the Role:As a Senior Director of Quality Assurance (GMP), you will be responsible for providing quality oversight of our clinical development programs and manufacturing. This role requires a strong background in biologics and operational QA experience with monoclonal antibodies.Key Responsibilities:- Provide quality support and guidance for our CMC...


  • Cambridge, Massachusetts, United States Jobot Full time

    We are a publicly traded biotechnology company developing innovative biologics to address chronic dermatological diseases.The estimated salary for this position is approximately $175,000 per year, considering the industry standard and location. The role requires an expert in biologics, specifically operational QA experience with monoclonal antibodies, and a...


  • Cambridge, Massachusetts, United States Jobot Full time

    We are a publicly traded biotechnology company developing innovative solutions to treat chronic dermatological diseases. Our team is seeking an experienced Senior Director of Quality Assurance (GMP) to provide quality oversight of our clinical development programs and manufacturing.Responsibilities:Provide quality support and guidance for our CMC...


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

    Key ResponsibilitiesThe Quality Assurance Lead will be responsible for developing and implementing quality assurance procedures to ensure that all analytical methods and data meet regulatory requirements. This includes overseeing CDMOs for phase-appropriate analytical method development, qualification, validation, and transfer for in-process testing, drug...


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

    About Marengo Therapeutics, Inc.Marengo Therapeutics is a pioneering biopharmaceutical company dedicated to developing innovative therapeutics that activate the right immune response to promote lifelong protection against cancer. Our team is passionate about making a meaningful difference in the lives of patients and their loved ones.Job OverviewWe are...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Takeda Pharmaceutical is seeking a highly motivated and experienced professional to fill the role of Director, Medical and Scientific Research.Key ResponsibilitiesAs a director, you will be responsible for overseeing the development of AI-driven projects, collaborating with cross-functional teams to design and execute experiments, and driving the analysis...


  • Cambridge, Massachusetts, United States WHITE COLLAR TECHNOLOGIES INC Full time

    About the RoleWe are looking for a talented Validation and Quality Assurance Professional to join our team at White Collar Technologies Inc. As a key member of our team, you will play a crucial role in ensuring the quality and compliance of our services.The salary for this position is $90,000 - $115,000 per year, depending on experience.Job DescriptionIn...


  • Cambridge, Massachusetts, United States Amylyx Pharmaceuticals Inc Full time

    As a leader in the pharmaceutical industry, Amylyx Pharmaceuticals Inc is committed to delivering innovative solutions to address complex medical challenges. We are seeking a talented Senior Quality Assurance Leader to join our team and drive excellence in quality management.This role will be responsible for developing and implementing quality management...