Contract Manufacturing Specialist

3 days ago


Dublin, Dublin City, Ireland Amgen SA Full time

About Our Company


Amgen SA is a global biotechnology leader, dedicated to improving health outcomes for patients worldwide. Our commitment to innovation drives us to push beyond conventional boundaries, exploring new avenues in human biology to develop novel treatments and therapies.



Job Overview


We are seeking a highly motivated Sr. Manager, Quality to join our team, responsible for leading quality assurance initiatives and ensuring compliance with regulatory requirements. The ideal candidate will have a strong background in quality management, contract manufacturing, and regulatory affairs.



Main Responsibilities



  • Develop and implement effective quality management systems to ensure compliance with regulatory requirements.
  • Lead quality audits and assessments to identify areas for improvement and optimize processes.
  • Maintain accurate records of quality events, deviations, and nonconformances.
  • Collaborate with internal partners and external stakeholders to ensure seamless communication and issue resolution.


Requirements


The ideal candidate should possess a Bachelor's degree and 6 years of directly related experience, or equivalent qualifications. Qualified Person status is essential, and additional European languages are desirable. A strong track record in project management, problem-solving, and analytical skills is required, along with excellent communication and collaboration skills.



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