QA Decentralized Manufacturing Unit Manager
4 weeks ago
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.
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