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QA Operations Decentralized Manufacturing Unit Manager US

Galapagos
Princeton, NJ Full Time
POSTED ON 2/24/2025
AVAILABLE BEFORE 5/23/2025

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.

We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The 'make-it-happener'.

We are looking for a QA Operations Decentralized Manufacturing Unit (DMU) Manager to join us in setting up, promoting and maintaining the QA model for our dynamic business environment.

Scope of the role

As QA Operations DMU Manager , you join our QA Operations team located in the United States. We are a fast-growing team, building a QA model for our expanding organization, working closely together with our decentralized manufacturing partners. This role requires regular traveling (approximately 50%) to the assigned DMU(s).

Your role

  • DMU manufacturing site qualification and onboarding.
  • DMU manufacturing quality monitoring.
  • DMU quality and compliance oversight to enhance consistency.

Representing GLPG and performing "QA on the floor" functions when required at the DMU.

  • Ensuring the GLPG quality management system is followed at the DMU.
  • Ensuring GLPG provides quality support to the DMU during clinical manufacturing.
  • Maintaining product quality oversight, creating consistency using GLPGs Central 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.
  • Reviewing environmental monitoring data.
  • Who are you?

  • Bachelor's degree in Life Science, Engineering or related field.
  • At least 3 years of experience in a QA Operations role within a GMP environment with thorough working knowledge of cGMP QA processes.
  • Experience in an ATMP manufacturing setting, preferably in the CAR-T space.
  • Able to travel regularly for on-site visits to DMUs across the US for F2F interaction with stakeholders and "QA on the floor" tasks.
  • You enjoy working in a fast-paced small company environment, with minimal direction, and are able to adjust your workload based on changing priorities.
  • Excellent project and stakeholder management skills; able to engage and motivate teams.
  • 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.

    Base compensation for this position ranges from $106.875 to $178.125. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time.

    In addition, this position is eligible for participation in Galapagos' performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.

    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.

    We are Galapagos : together, we make it happen...!

    Salary : $106,875 - $178,125

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