Director of Quality Operations

4 weeks ago


Cambridge, Massachusetts, United States Meet Full time

Job Title: Director of Quality Operations

Summary:

The Director of Quality Operations is responsible for overseeing commercial product distribution and maintaining Good Distribution Practices (GDP) for the US affiliate. This role manages third-party logistics providers, handles product release for distribution, and ensures compliance with GDP regulations and internal quality standards. Reporting to the Senior Director, this position collaborates with internal teams and manages vendor relationships to support the successful distribution of commercial drug products.

Key Responsibilities:

  • Oversee day-to-day operations of third-party logistics providers and manage product release for distribution.
  • Maintain relationships with manufacturing and distribution channels.
  • Handle temperature excursions, product replacement requests, serialization issues, and logistics complaints.
  • Develop and maintain Quality Technical Agreements and oversee temperature-controlled shipping qualifications.
  • Own the Vendor Management and external audit program, ensuring GDP compliance.
  • Manage deviations, CAPAs, and change controls related to GDP.
  • Update annual GDP training materials and maintain training records.
  • Track and report on GDP-related KPIs and metrics.

Requirements:

  • Bachelor's degree or higher, preferably in a science-related field.
  • 12+ years of experience in Quality, with oversight of GDP and third-party logistics in a pharmaceutical or similar environment.
  • Experience with SAP and electronic quality management systems preferred.

This role offers the opportunity to lead quality operations and ensure compliance with GDP standards for commercial drug distribution.



  • Cambridge, Massachusetts, United States Meet Full time

    Job Title: Associate Director, Quality OperationsJob Summary:We are seeking an experienced Associate Director, Quality Operations to oversee commercial product distribution and maintain Good Distribution Practices (GDP) for our US affiliate. This role will manage third-party logistics providers, handle product release for distribution, and ensure compliance...


  • Cambridge, Massachusetts, United States Vericel Corporation Full time

    Quality Operations DirectorVericel Corporation, a leader in advanced therapies, seeks a top performing Quality professional to join its commercial stage company. The successful candidate will oversee the Quality Assurance, Document Control, and Quality Supplier Management departments, ensuring compliance with regulations and industry standards.Key...


  • Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full time

    Job Title:Director, Administration and FinanceJob Summary:We are seeking a highly experienced and skilled Director of Administration and Finance to join our team at the Massachusetts Institute of Technology. The successful candidate will be responsible for providing strategic leadership and management of the Sociotechnical Systems Research Center's...


  • Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full time

    Senior Finance and Operations ManagerAt the Massachusetts Institute of Technology, we are seeking a highly skilled Senior Finance and Operations Manager to join our team. This role will be responsible for supporting our mission to reduce poverty and fight climate change by ensuring that policy is informed by scientific evidence.Key Responsibilities:Financial...


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

    Job Title: Operating Room Assistant DirectorMass General Brigham is seeking a highly skilled and experienced Registered Nurse to fill the role of Operating Room Assistant Director. This is a unique opportunity to join a dynamic team and contribute to the delivery of exceptional patient care.Job Summary:The Operating Room Assistant Director will provide...


  • Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled Associate Director, PV Quality to join our team. The successful candidate will provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers.The Associate Director, PV Quality will lead the development of...


  • 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 Ipsen Pharma Full time

    Job Title: Regulatory Operations DirectorAt Ipsen Pharma, we are seeking a highly skilled Regulatory Operations Director to join our team. This is a key leadership role that will be responsible for formulating and implementing operational management creating a best-in-class US regulatory operations team and technology leadership/ownership of Ipsen's...


  • Cambridge, Massachusetts, United States Compass Group, North America Full time

    At Compass Group, North America, we're committed to delivering exceptional food and hospitality services that exceed our clients' expectations. As an Executive Director of Culinary Operations, you'll play a pivotal role in leading our team to success.**Job Summary**We're seeking a highly skilled and experienced Executive Director of Culinary Operations to...


  • Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking an experienced Associate Director, PV Quality to provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers. The successful candidate will provide compliance support to the Moderna PV organization, establish and...


  • Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full time

    Job Summary:We are seeking a highly skilled and experienced Director of Financial Administration and Operations to join our team at the Massachusetts Institute of Technology. The successful candidate will be responsible for managing the financial review and control for business administration and finance functions, as well as overseeing the negotiation of...


  • 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. The ideal candidate will have a strong background in biologics, specifically operational QA experience with monoclonal antibodies, and expertise in partnering with external manufacturers.Key...


  • 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 Randstad Full time

    Job Title: Associate Director Data OperationsWe are seeking a highly skilled Associate Director Data Operations to join our team at Randstad. This is a contract position based in Cambridge, Massachusetts, with a salary range of $56.47 - $74.99 per hour.Job Summary:The Associate Director Data Operations will be responsible for supporting Digital Health...


  • Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled and experienced Associate Director, PV Quality to join our team. The successful candidate will be responsible for providing quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers.The Associate Director, PV...


  • Cambridge, Massachusetts, United States Ipsen Pharma Full time

    Job Title: Director, Regulatory Operations Company: Ipsen Biopharmaceuticals Inc. Job Description: As a key member of the US Regulatory and Quality leadership team, the Director of Regulatory Operations will be responsible for formulating and implementing operational management strategies to create a best-in-class US regulatory operations team. This role...


  • Cambridge, Massachusetts, United States InterSystems Full time

    The Director of Quality Development will oversee the managers responsible for the quality of our IRIS product. This person will collaborate extensively with other department leaders to ensure a high-quality delivery of our products to Solution Partners and End Users.Duties and Responsibilities:Lead a team of Managers responsible for overseeing individual...


  • Cambridge, Massachusetts, United States Alnylam Full time

    About the RoleAlnylam is embarking on an accelerated growth trajectory, transitioning from an early commercial biotech to a larger biopharmaceutical company. The Director of Operational Transformation will play a pivotal role in enabling Alnylam's successful scaling and reinvention, driving business results and impacting patient lives.Key...


  • Cambridge, Massachusetts, United States QurAlis Full time

    Job Title: Director of External ManufacturingAt QurAlis, we are seeking a highly skilled and experienced Director of External Manufacturing to join our team. As a key member of our CMC team, you will play a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the refinement of external...


  • Cambridge, Massachusetts, United States Massachusetts Institute of Technology Full time

    Job Summary:We are seeking a highly motivated and experienced Quality Assurance and Operations Supervisor to join our team at the Massachusetts Institute of Technology. As a key member of our Custodial Services team, you will be responsible for providing supervision, resources, and direction to teams striving to achieve exceptionally high levels of...