Job Purpose The Senior Manager Quality (GMP) will provide oversight of MoonLake's manufacturing supply chain to ensure compliance with GMP, MoonLake’s regulatory dossiers and the release schedule; provide advice, support and the necessary oversight to client groups on GMP compliance within MoonLake and CDMOs; collaborate effectively with rest of MoonLake's Quality team and consultants, representing Quality on specific project teams. Key Accountabilities: <ul><li>Become familiar with MoonLake's products, technical agreements, regulatory dossiers and subcontracted manufacturing supply chain</li><li>Maintain awareness of international GMP compliance requirements for Investigational Medicinal Products, Biotech API and drug product manufacture including the GCP interface</li><li>Become familiar with MoonLake's quality systems (contributing to their maintenance and ongoing improvement)</li><li>Ensure GXP compliance of contractors for API manufacture and testing, taking responsibility for QA contact with CMO/CTO on set-up, deviations and change assessment and batch review</li><li>Provide advice on GMP to client groups within MoonLake, providing necessary oversight to ensure compliance</li><li>Become familiar with MoonLake's drug product manufacture and packed stock release procedures and ensure QPs are made aware of any compliance issues which could impact upon the safety of MoonLake's clinical products</li><li>Provide QA support to validation activities at CMOs/CTOs</li><li>Undertake other quality assurance duties as required</li></ul> Your profile Education: Scientific degree (ideally pharmacy, pharmaceutical sciences, Biology, chemistry or related). Experience: Demonstrable track record and skills/experience gained in Quality functions in multinational pharmaceutical/biotech environment, specifically in batch review/manufacturing oversight. Skills/knowledge/behavioural competencies:<ul><li>Good understanding of biologics drug substance manufacturing process</li><li>Some experience in aseptic manufacture of biologic DP and/or combination products is desirable</li><li>Some knowledge of validation requirements within the Bio/Pharmaindustry</li><li>Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. </li><li>Credible and confident communicator (written and verbal) at all levels. </li><li>Strong analytical and problem-solving ability. </li><li>Self-motivated, with the ability to work proactively using own initiative</li><li>Audit skills would be an advantage but not essential for this role.</li></ul>Work Location:<ul><li>2 days a week in our brand new Porto or Zug offices.</li></ul> Why us? An exciting job opportunity awaits you! MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team. What we offer: Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment. Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare. Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team. Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills. Our Core Values We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence: We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always. We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other. We unlock value: We aspire to create long-term value for investors and communities.

Senior Manager Quality (GMP) @ Moonlaketx

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