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Senior Manager, Device Quality Expert

2 months ago


Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

{"h1": "Senior Manager, Device Quality", "p": "At MoonLake Immunotherapeutics, we are seeking a highly skilled Senior Manager, Device Quality to join our team. As a key member of our Quality Team, you will be responsible for defining and implementing a Device Quality Management System (QMS) that meets regulatory requirements and supports the development of our drug-device combination products.", "ul": [{"li": "Develop and maintain a comprehensive QMS that ensures compliance with regulatory requirements and industry standards."}, {"li": "Collaborate with cross-functional teams to identify and mitigate quality risks associated with device development."}, {"li": "Provide expert advice and guidance on device quality requirements to the Drug-Device Development Team."}, {"li": "Work with vendors to ensure compliance with quality and regulatory requirements."}, {"li": "Develop and implement quality systems and procedures to ensure effective quality management."}], "h2": "Requirements", "ul": [{"li": "Bachelor\u2019s degree in a relevant field, such as scientific degree, pharmaceutical science, biology, or chemistry."}, {"li": "Minimum 5+ years of experience in a similar role, with a strong background in device quality management."}, {"li": "Excellent communication and interpersonal skills, with the ability to influence and collaborate with cross-functional teams."}, {"li": "Strong analytical and problem-solving skills, with the ability to identify and mitigate quality risks."}, {"li": "Ability to work in a fast-paced environment, with a strong attention to detail and ability to meet deadlines."}], "h2": "What We Offer", "p": "At MoonLake Immunotherapeutics, we offer a dynamic and innovative work environment, with opportunities for career growth and professional development. We are committed to providing our employees with the tools and resources they need to succeed, and we offer a competitive compensation and benefits package.", "h2": "About Us", "p": "MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company dedicated to unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory diseases. We are committed to making a positive impact on the lives of patients and to advancing the field of immunotherapy.", "h2": "Join Our Team", "p": "If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity. Please submit your resume and a cover letter outlining your qualifications and experience.", "h2": "Contact Us", "p": "For more information about this opportunity, please contact us at [insert contact information]."}