Senior Compliance Quality Manager

4 weeks 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 vibrant and forward-thinking team. In this pivotal role, you will ensure that quality remains a fundamental focus across all organizational initiatives, particularly by providing guidance to the Clinical Development teams regarding GCP practices.

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
  • Identify and supervise external contracted organizations engaged in GxP operations
  • Evaluate the performance of service providers and conduct GCP audits as required
  • Track quality metrics and relay compliance performance to senior leadership
  • Guarantee alignment with pertinent 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 challenges within biotechnology or biopharmaceutical settings
  • In-depth knowledge of GCP regulations and industry standards for clinical trials
  • Exceptional communication, negotiation, and conflict resolution abilities
  • Familiarity with GLP and GMP standards applicable to biologics
  • Capacity to collaborate effectively and devise practical solutions in a dynamic environment
Location: Flexible work arrangement with some travel required

Why Join Us?

At MoonLake Immunotherapeutics, you will benefit from:

  • An opportunity for professional growth within a supportive and innovative biotech setting
  • The chance to contribute to significant projects that aim to transform global healthcare
  • Flexibility for remote or hybrid work to maintain a healthy work-life balance
  • A clear trajectory for career advancement and development
Core Values:
  • We do Stellar Science - Developing novel therapies through innovative science and exceptional quality
  • We go beyond - Embracing positive disruption and boldness in challenging the status quo
  • We unlock value - Fostering long-term value for investors and communities
About MoonLake Immunotherapeutics

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

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