Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Director, QA & Regulatory Affairs - Clinical Research

Mass General Brigham

Mass General Brigham NCRI seeks a Director of Quality Assurance and Regulatory Affairs to lead QA strategies, audits, and regulatory programs across clinical trials, ensuring FDA and ICH/GCP compliance. You will oversee 10+ QA staff, coordinate with regulators and study teams, develop corrective action plans, and maintain training and SOPs, partnering with NCRI leadership to advance clinical neuroscience research. #J-18808-Ljbffr Mass General Brigham

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Director, QA & Regulatory Affairs - Clinical Research in Somerville, MA vacancy
  • Mass General Brigham's NCRI unit seeks a Director of Quality Assurance and Regulatory Affairs to lead the organization’s QA programs across clinical trials, audits, and regulatory...  ...role requires 8-10+ years in clinical research QA with leadership experience and a bachelor... 
    Suggested

    Mass General Brigham

    Somerville, MA
    2 days ago
  •  ...Hospital Corporation is seeking a Regulatory Coordinator for the Neurological Clinical Research Institute (NCRI) at...  ...Hospital. This role focuses on QA, regulatory affairs, SOP development, and staff training...  .... Reporting to the NCRI Director, Quality Assurance, the position... 
    Suggested

    The General Hospital Corporation

    Somerville, MA
    1 day ago
  • Mass General Brigham is seeking a Quality Assurance Manager for the Neurological Clinical Research Institute (NCRI) at 399 Revolution Drive, Boston. This role directs QA activities across clinical studies, ensuring adherence to GCP, regulations, and the NCRI Quality Management... 
    Suggested

    Mass General Brigham

    Somerville, MA
    2 days ago
  • Mass General Brigham is seeking a Director of Quality Assurance and Regulatory Affairs to oversee QA programs and regulatory compliance across the organization...  ...corrective actions, develops SOPs and QA tools for clinical research, and partners with NCRI leadership to advance... 
    Suggested

    Mass General Brigham

    Somerville, MA
    1 day ago
  • Mass General Brigham's Neurological Clinical Research Institute seeks a Regulatory Coordinator to manage QA activities, SOP development, and regulatory compliance across NCRI and investigative sites. You will draft procedures, train staff on GCP, and support audits and... 
    Suggested

    Mass General Brigham

    Somerville, MA
    2 days ago
  •  ...people, tech experts, researchers, and systems analysts...  ...assurance and regulatory affairs for the organization,...  ...Details (if applicable)Directors of the NCRI, the Director...  ...MGH NCRI to conduct clinical trials under FDA and...  ...Assurance and Regulatory (QA) team• Develop,... 
    Remote work

    Mass General Brigham

    Somerville, MA
    3 days ago
  • Mass General Brigham seeks a Director of Quality Assurance and Regulatory Affairs to oversee QA programs and regulatory compliance across the NCRI. You will lead audits, risk assessments, and investigations, collaborating with leadership to strengthen care quality and... 

    The General Hospital Corporation

    Somerville, MA
    4 days ago
  • $250k - $300k

     ...Repertoire Immune Medicines is a clinical-stage biotechnology company harnessing...  ...therapies designed to selectively expand regulatory T cells and reset the immune system....  ...is seeking an experienced Senior Director of Regulatory Affairs to serve as the company’s first... 
    Temporary work
    Work experience placement
    Work at office
    Flexible hours
    3 days per week

    Repertoire Immune Medicines

    Watertown, MA
    2 days ago
  • Mass General Brigham seeks a Regulatory Coordinator to manage QA and regulatory activities for NCRI, focusing on GCP compliance, audits, and site...  ...to regulations. The role requires 3+ years in clinical research or QA, a scientific degree, and strong leadership and... 
    Remote work

    Mass General Brigham

    Somerville, MA
    3 days ago
  • $63.25k - $102.6k

     ...people, tech experts, researchers, and systems analysts to...  ...Manager and/or Project Director of a large global clinical study. This position has...  ...agencies and other regulatory bodies. Collecting, reviewing...  ..., Quality Assurance (QA) and Regulatory Affairs, the Regulatory... 
    Work experience placement
    Work at office
    Remote work
    Shift work

    Massachusetts General Hospital

    Somerville, MA
    2 days ago
  • $166.4k - $249.6k

     ...Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for...  ...Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical...  ...acromegaly, and it continues to advance clinical and research programs in these areas. Vertex... 
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals Inc (US)

    Boston, MA
    4 days ago
  •  ...of Position:Looking for an associate or director-level subject matter expert to build clinical operations compliance while upholding our...  ...cross-functional team members within Regulatory, Quality, Data Sciences, Clinical Research, Pharmacovigilance, and other key cross-... 
    Work at office
    Flexible hours

    Planet Pharma

    Somerville, MA
    16 hours ago
  • $170k - $180k

    Director of Quality & Regulatory Affairs Department: Quality Employment Type: Full Time Location: Burlington,...  ...care, and return to work. Published clinical research shows a clinically significant...  ...Regulatory Affairs leads the global QA/RA function and is responsible for... 
    Full time

    Myomo, Inc

    Burlington, MA
    3 days ago
  •  ...developing and maintaining the Regulatory Sciences compliance framework...  ...product lifecycle from Good Clinical Practice (GCP) through Good...  ...collaboration accountable owners QA partners. Ensure appropriate...  ...’s degree in Regulatory Affairs, Life Sciences, Pharmacy, or... 
    Full time
    Temporary work
    Local area
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    16 hours ago
  •  ...GroupContact: ApplicationsEmail: ****@*****.*** OverviewPlanet Pharma’s clinical-stage biotechnology client is seeking an experienced Senior Director of Regulatory Affairs to serve as the company’s first internal Regulatory Affairs hire and senior... 
    Work at office
    3 days per week

    Planet Pharma

    Somerville, MA
    16 hours ago
  •  ...business people, tech experts, researchers, and systems analysts to...  ...quality assurance and regulatory affairs for the organization, ensuring...  ...Job Details (if applicable) Directors of the NCRI, the Director of...  ...the MGH NCRI to conduct clinical trials under FDA and institutional... 
    Remote work

    The General Hospital Corporation

    Somerville, MA
    4 days ago
  • Sarepta Therapeutics is seeking a Director, Corporate Quality to lead GCP/GLP QA across Clinical Development and Real-World...  ...Clinical, Pharmacovigilance, and Research teams to uphold patient safety...  ...external and internal audits and regulatory inspections. #J-18808-Ljbffr... 

    Sarepta Therapeutics

    Cambridge, MA
    16 hours ago
  • $171.75k - $286.25k

     ...development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision...  ...additional experience ex US and EU preferred.Experience with clinical trial and licensing requirements for Precision Medicine and Digital... 
    Full time
    Temporary work
    Local area
    Remote work
    Work from home
    Worldwide

    GSK

    Waltham, MA
    2 days ago
  • $210k - $320k

     ...cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence... 
    Full time
    Shift work
    3 days per week
    1 day per week

    Beam Therapeutics

    Cambridge, MA
    3 days ago
  •  ...Summary The Senior Director, Regulatory Affairs leads and coordinates regulatory interactions and submission execution for ARTBIO’s clinical-stage radiopharmaceutical programs. This role...  ...works cross-functionally to translate research and development data and strategy... 
    Contract work

    Artbio

    Cambridge, MA
    3 days ago
  • $207k - $253k

     ...ensure we have the right talent, at the right time, in the right way. The Director of Regulatory Affairs CMC provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions,... 
    Minimum wage
    Full time
    Work at office
    Local area
    Flexible hours
    3 days per week

    Regulatory Toolkit

    Waltham, MA
    1 day ago
  •  ...company dedicated to drug discovery, clinical development, and commercialization...  ...study, X-TOLE3, which would support regulatory submissions outside the U.S., and the...  ...This position reports to the Executive Director, Regulatory Affairs, CMC, and will be based out of... 
    Temporary work
    Work at office
    Remote work
    2 days per week

    Xenon Pharmaceuticals Inc.

    Needham, MA
    4 days ago
  • $215k - $235k

     ...Arbor Biotechnologies, a clinical stage, next-generation gene editing company based in Cambridge, MA, is advancing a portfolio...  ...like you then please read on! About the Role: The Director of Regulatory Affairs is responsible for leading regulatory strategy and... 

    Arbor Biotechnologies Inc

    Cambridge, MA
    3 days ago
  • $227.9k - $308.3k

    Overview:The Senior Director, Global Pharmacovigilance Quality Assurance...  ...direction for the GVP QA function and provides independent...  ...excellence, and long-term regulatory compliance.This role can be based...  ...Safety, Quality, Regulatory, Clinical, Commercial, and enterprise... 
    Full time
    Temporary work
    Local area
    Remote work
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    1 day ago
  •  ...The QA Manager serves as the Quality Assurance representative for commercial finished goods and external manufacturing partners. This...  ...to ensure compliance with internal standards and global regulatory requirements. The position partners closely with contract manufacturers... 
    Contract work

    Meet Life Sciences

    Cambridge, MA
    2 days ago
  •  ...Job title: Medical Director Pulmonary ~ Location: Cambridge...  ...Sanofi Immunology Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on...  ...Outcomes, Safety, and Clinical Research including Phase IIIB-IV... 
    Local area

    Sanofi Group

    Cambridge, MA
    3 days ago
  •  ...in 1947, Pulpdent Corporation is an industry-leading dental research and development (R&D) and manufacturing company. Pulpdent’s...  ...practices, visit pulpdent.com. Job Summary The Head of Regulatory Affairs will lead and evolve Pulpdent’s global regulatory strategy across... 

    Pulpdent Corporation

    Watertown, MA
    2 days ago
  •  ...Director, Regulatory Affairs, Global Labeling Strategy (US) Overview The Director of Global Labeling...  ...plans by partnering early with Clinical Development, Biostatistics, Medical,...  ...Use approved AI tools and advanced research approaches responsibly to accelerate... 
    Local area

    Jobleads-US

    Cambridge, MA
    2 days ago
  • Job Description Position Overview The Quality & Regulatory Affairs Manager is responsible for ensuring organizational compliance with applicable...  ...Structure This position reports to the: President Director of Engineering Director of Operations #J-18808-Ljbffr Energy... 
    Work at office

    Energy Jobline ZR

    Watertown, MA
    3 days ago
  • $216.3k - $324.5k

     ...Job Description Senior Director, Regulatory Transformation & Innovation Job Summary...  ...initiatives across Global Regulatory Affairs (GRA). This Senior Director will define...  ...acromegaly, and it continues to advance clinical and research programs in these areas. Vertex... 
    Summer work
    Remote work
    Flexible hours
    2 days per week
    3 days per week

    Vertex Pharmaceuticals Inc (US)

    Boston, MA
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director, QA & Regulatory Affairs - Clinical Research. Be the first to apply!