QA Decentralized Manufacturing Unit Manager

4 weeks ago


Princeton, New Jersey, United States Galapagos Full time
Job Title: QA Decentralized Manufacturing Unit Manager

We are seeking a highly skilled QA Decentralized Manufacturing Unit Manager to join our team at Galapagos. As a key member of our Quality Assurance team, you will be responsible for setting up, promoting, and maintaining the QA model for our dynamic business environment.

Key Responsibilities:

  • DMU manufacturing site qualification and onboarding
  • DMU manufacturing quality monitoring
  • DMU compliance oversight to enhance consistency
  • Quality oversight of DMUs by representing GLPG and ensuring GLPG quality management system is followed at DMU
  • Maintaining product quality oversight, creating consistency using Galapagos Central Reference Site capabilities and data
  • Conducting real-time batch records review
  • Ensuring DMUs complete Deviations, CAPAs, and Change Control Records on time
  • Ensuring DMU personnel assigned to work on GLPG manufacturing and/or testing are adequately trained

Requirements:

  • Life Science or Engineering Bachelor's degree
  • At least 3 years of experience in QA Operations role within a GMP environment with thorough working knowledge of cGMP QA processes
  • Experience in a ATMP manufacturing setting is preferred
  • Experience in a commercial GMP manufacturing setting is preferred
  • Proficient in project management
  • Ability to travel for on-site visits to DMU sites for F2F interaction with stakeholders and QA on the Floor tasks
  • Result-driven and can-do mindset, without compromising quality and compliance
  • Independent thinker and resourceful
  • Good interpersonal skills

What's in it for you?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation. We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being.

We are Galapagos:

Together we can make it happen...Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.



  • Princeton, New Jersey, United States Dow Jones Full time

    About the RoleThe Senior Analyst QA Operations will report to the Manager within the Marketing Data Platforms Team. The team carries out a variety of functions that ensure the proper collection of customer data to support key lifecycle activities such as billing, price increases, and customer communications.You will be responsible for developing and...


  • Princeton, New Jersey, United States L.W. Schneider, Inc Full time

    Job SummaryL.W. Schneider, Inc is seeking a skilled Manufacturing Design Engineer to manage a combination of manufacturing and engineering tasks and special projects. The ideal candidate will have a strong background in tool and fixture design, as well as experience with CNC machine programming and project management.Key Responsibilities:Design and implement...


  • Princeton, New Jersey, United States Galapagos Full time

    Job SummaryWe are seeking a highly experienced Quality Assurance Associate Director to lead our Quality Control operations in the US. As a key member of our team, you will be responsible for ensuring the highest standards of quality, compliance, and regulatory adherence in our Quality Control activities.Key ResponsibilitiesLead Quality Management System...


  • Princeton, New Jersey, United States Experis Full time

    Job Title: Investigator, MS&T (Manufacturing Science and Technology)Job Summary:We are seeking a highly skilled Investigator, MS&T (Manufacturing Science and Technology) to join our team at Experis. As a key member of our manufacturing team, you will be responsible for providing technical support and expertise in gene and cell therapy manufacturing...


  • Princeton, New Jersey, United States ZS Full time

    Unlock Your PotentialAt ZS, we're passionate about helping our clients solve complex problems and improve their business operations. As a Manufacturing Consultant, you'll play a key role in driving innovation and delivering world-class technology solutions. Our team is dedicated to fostering a culture of collaboration, creativity, and continuous learning. If...


  • Princeton, New Jersey, United States Catalent Inc Full time

    Job Title: Director MS&T and OperationsLocation: Princeton, NJPOSITION SUMMARYThe Director of MS&T and Operations is responsible for leading teams while overseeing the GMP manufacturing, and MS&T processes, through the broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of cell therapy...


  • Princeton, New Jersey, United States Catalent Inc Full time

    Catalent Pharma Solutions in Princeton, NJ is seeking a Manufacturing Science and Technology (MSAT) Process Engineer to provide technical support to the Princeton, NJ Facility (CPNJ) Manufacturing processes in a GMP environment.The ideal candidate will troubleshoot process and equipment related issues that occur during the Manufacturing process, working...


  • Princeton, New Jersey, United States Integra LifeSciences Full time

    Job SummaryIntegra LifeSciences is seeking a Senior Process Engineer to support product development and manufacturing operations activities. The successful candidate will be responsible for assessing the feasibility of new manufacturing processes and assisting in their development and validation.Key ResponsibilitiesWork as part of a cross-functional team to...


  • Princeton, New Jersey, United States Hydro Gear Partnership Full time

    Job Title: Manufacturing Engineer Machining SpecialistJob Summary: We are seeking a highly skilled Manufacturing Engineer Machining Specialist to join our team at Hydro-Gear's Princeton KY plant. The successful candidate will be responsible for designing, building, programming, and supporting the automated systems that assemble our cutting-edge products.Key...


  • Princeton Junction, New Jersey, United States Shiseido Full time

    Job Summary: As a Senior Product Launch Manager at Shiseido Americas, you will lead a category within the New Product Commercialization SAI team in executing launches to deliver OTIF. You will manage a specific portfolio of projects and lead a team of planners/senior planners. The New Product Commercialization team is responsible for collaborating with all...


  • Princeton Junction, New Jersey, United States Empower Pharmacy Full time

    Empower Pharmacy: A Leader in Pharmaceutical InnovationAt Empower Pharmacy, we are committed to delivering high-quality, innovative medications to patients across the nation. As a Senior Aseptic Manufacturing Operator, you will play a critical role in ensuring the production of sterile products that meet our stringent quality standards.Key...


  • Princeton, New Jersey, United States InsideHigherEd Full time

    Job SummaryThe Associate Registrar for Curriculum and Scheduling is a key member of the Office of the Registrar, providing strategic leadership and oversight for curriculum, degree progress, and classroom scheduling. This role requires a strong understanding of academic policies and procedures, as well as excellent communication and management...

  • Pharmacy Manager

    3 weeks ago


    Princeton, New Jersey, United States Walmart Full time

    Job SummaryWe are seeking a highly skilled and experienced Pharmacy Manager to lead our pharmacy team at Walmart. As a Pharmacy Manager, you will be responsible for overseeing the daily operations of the pharmacy, ensuring compliance with regulatory requirements, and providing exceptional patient care.Key ResponsibilitiesOversee the daily operations of the...


  • Princeton, New Jersey, United States gonzer Full time

    Job Summary:We are seeking a highly skilled Mechanical Project Manager to join our team at Gonzer. As a key member of our operations team, you will be responsible for overseeing the installation and modification of mechanical systems in our facilities.Key Responsibilities:Review and prepare modification documents, including installation procedures, as...


  • Princeton, New Jersey, United States Munich Re Full time

    We're seeking a highly skilled Risk Management Strategist to join our team at Munich Re US. As a key member of our risk management framework, you'll play a significant role in identifying and mitigating risks, ensuring our business units operate with confidence and stability.Key responsibilities include:Monitoring and reporting on risk management processes...


  • Princeton, New Jersey, United States Dow Jones Full time

    About the RoleThe Senior Analyst QA Operations will report to the Manager within the Marketing Data Platforms Team. The team carries out a variety of functions that ensure the proper collection of customer data to support key lifecycle activities such as billing, price increases, and customer communications.You will be responsible for developing and...


  • Princeton, New Jersey, United States gonzer Full time

    Job SummaryWe are seeking a highly experienced Mechanical Engineer with strong project management skills to join our team at Gonzer. The successful candidate will be responsible for leading the installation and modification of electrical, instrumentation, and control systems in a highly regulated work environment.Key ResponsibilitiesLead the preparation of...


  • Princeton, New Jersey, United States Sandoz Full time

    Job SummaryWe are seeking a highly skilled Government Pricing Manager to join our team at Sandoz. As a key member of our Government Pricing team, you will be responsible for supporting the calculation, validation, and analytics related to our participation in government programs, including Medicaid, Medicare Part B, VA Federal Supply Schedule, and PHS 340B...

  • Principal Engineer

    4 weeks ago


    Princeton, New Jersey, United States Pennoni Full time

    Job Title: Principal Engineer - Project ManagerPennoni is a multidisciplinary consulting engineering firm seeking a Principal Engineer who can also serve as our Project Manager to join our Land Development team in a leadership role.Key Responsibilities:Oversee the preparation of civil/site engineering designs & plans for jurisdictional approval as well as...


  • Princeton, New Jersey, United States Proconex Full time

    Job Title: Life Sciences Sales and Account ManagerProconex is seeking a highly motivated and experienced Sales and Account Manager to join our team in the Life Sciences industry. As a key member of our sales team, you will be responsible for managing and expanding our existing accounts within the Life Sciences sector.Key Responsibilities:Develop and execute...