Director Quality Operations

3 weeks ago


Cambridge, United States EPM Scientific Full time

Quality Operations Director



Key Responsibilities:

  • Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments.
  • Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards.
  • Maintain and oversee a robust quality management system.
  • Collaborate effectively with cross-functional teams to ensure seamless product launches.
  • Proactively identify, assess, and mitigate quality risks.
  • Oversee the Quality Operations department, including 11 direct reports



Qualifications:

  • Bachelor's degree in a relevant field, with a minimum of 14 years of experience (10+ years in Quality, 8+ years managing quality personnel). Alternatively, a Master's degree with a minimum of 12 years of experience (10+ years in Quality, 8+ years managing quality personnel) is acceptable. Prior leadership experience is essential.
  • In-depth understanding of regulatory requirements for the biopharmaceutical and/or medical device industry.
  • Excellent written and verbal communication skills.
  • Demonstrated ability to lead and develop a high-performing team.



Preferred Qualifications:

  • Prior experience in the medical device or biotechnology industry (biologics)
  • Internal and external quality audit oversight



  • Cambridge, United States EPM Scientific Full time

    Quality Operations Director Key Responsibilities: Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments. Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards. Maintain and oversee a robust quality management system. Collaborate effectively with...


  • Cambridge, United States EPM Scientific Full time

    Quality Operations Director Key Responsibilities: Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments. Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards. Maintain and oversee a robust quality management system. Collaborate effectively with...


  • Cambridge, United States EPM Scientific Full time

    Quality Operations Director Do you have the skills to fill this role Read the complete details below, and make your application today. Key Responsibilities: Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments. Oversee implementation and adherence to cGMP, ICH, FDA, and ISO...


  • Cambridge, United States EPM Scientific Full time

    Quality Operations DirectorKey Responsibilities:Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments.Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards.Maintain and oversee a robust quality management system.Collaborate effectively with...


  • Cambridge, United States Adaptimmune Therapeutics Plc Full time

    Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our company...


  • Cambridge, United States Sarepta Therapeutics Full time

    The Director will be responsible for the program level QA oversight of clinical studies. This position will be a core member of the Clinical Trial team and provide Clinical Trial team support and promote collaboration to ensure all clinical trial activities and outcomes are compliant with FDA Regulations, ICH guidelines, and applicable international...


  • Cambridge, United States Vericel Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Quality...


  • Cambridge, United States Vericel Corporation Full time

    Job DescriptionJob DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics....


  • Cambridge, United States Vericel Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Quality...


  • Cambridge, United States Vericel® Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Quality...


  • Cambridge, United States Vericel® Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Quality...


  • Cambridge, United States Vericel® Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Quality...


  • Cambridge, United States Office of the Secretary of Transportation Full time

    Summary The Director of Volpe National Transportation Systems Center (Volpe) Operations provides executive level oversight and management of all Operations functions, in a fee-for-service business model, including those with cross management to HQ organizations as part of a shared services initiative and ensures that their activities are conducted in...


  • Cambridge, United States Cambridge Health Alliance Full time

    Cambridge Health Alliance, a well-respected, nationally recognized and award-winning public healthcare system, is seeking a full-time Director of Outpatient Psychiatry Operations. The CHA Outpatient Psychiatry Department is a state-designated community behavioral health center and is a growing service in need of an experienced, energetic, effective leader...


  • Cambridge, United States Cambridge Health Alliance Full time

    Cambridge Health Alliance, a well-respected, nationally recognized and award-winning public healthcare system, is seeking a full-time Director of Outpatient Psychiatry Operations. The CHA Outpatient Psychiatry Department is a state-designated community behavioral health center and is a growing service in need of an experienced, energetic, effective leader...


  • Cambridge, United States Cambridge Health Alliance Full time

    Cambridge Health Alliance, a well-respected, nationally recognized and award-winning public healthcare system, is seeking a full-time Director of Outpatient Psychiatry Operations. The CHA Outpatient Psychiatry Department is a state-designated community behavioral health center and is a growing service in need of an experienced, energetic, effective leader...


  • Cambridge, United States Scholar Rock Full time

    Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...


  • Cambridge, United States Intellia Therapeutics, Inc. Full time

    Associate Director, Quality Systems Compliance page is loaded Associate Director, Quality Systems Compliance Apply locations Cambridge, MA time type Full time posted on Posted 5 Days Ago job requisition id R979 Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe...


  • Cambridge, United States Scholar Rock Full time

    Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...


  • Cambridge, United States Foghorn Therapeutics Inc. Full time

    Our Culture: Why work with us? At Foghorn Therapeutics, we believe in "People First, Mission Always." We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics - demonstrated by our community...