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Lead Quality Assurance Specialist

3 months ago

Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time
Join Our Team as a Senior Quality Expert (GCP)

MoonLake Immunotherapeutics is seeking a Senior Quality Expert (GCP) to enhance our dedicated and forward-thinking team. In this pivotal role, you will ensure that quality remains a fundamental aspect of all organizational initiatives, particularly by guiding the Clinical Development teams on Good Clinical Practice (GCP) activities.

Key Responsibilities:
  • Oversee and manage the GxP Quality Management System to ensure adherence to regulatory standards
  • Assist Clinical Development teams in establishing compliant procedures and addressing quality challenges
  • Evaluate and supervise external contracted organizations involved in GxP operations
  • Assess the performance of service providers and perform GCP audits as required
  • Track quality metrics and relay compliance performance to upper management
  • Guarantee adherence to applicable quality standards and protocols
Your Profile

Requirements:
- A scientific degree in pharmaceutical sciences, biology, or a related discipline
- At least 5 years of experience in quality management positions

Skills:

  • Demonstrated experience in managing quality concerns within biotechnology or biopharmaceutical settings
  • Familiarity with GCP regulations and industry standards for clinical trials
  • Excellent communication, negotiation, and conflict resolution abilities
  • Knowledge of GLP and GMP standards for biologics
  • Capacity to collaborate effectively and devise practical solutions in a dynamic environment
Location: Hybrid work model with office presence required on select days and occasional travel

Why Choose MoonLake Immunotherapeutics?

At MoonLake Immunotherapeutics, you will experience:

  • An opportunity for professional growth in a nurturing and innovative biotech setting
  • The chance to contribute to significant projects that aim to transform global healthcare
  • Flexibility for remote or hybrid work arrangements to support a balanced lifestyle
  • A defined pathway for career advancement and personal development
Core Values:
  • We prioritize Stellar Science - Developing groundbreaking therapies through innovative science and exceptional quality
  • We embrace disruption - Challenging the status quo with boldness and positivity
  • We create lasting value - Fostering long-term benefits for investors and communities
About Us

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical organization dedicated to developing therapies for inflammatory diseases. Our current focus includes conditions such as hidradenitis suppurativa and psoriatic arthritis. Join us in our mission to enhance patient outcomes through innovative treatment solutions.