AS THE DIRECTOR QUALITY GCP, YOU WILL LEAD A TEAM OF GCP QUALITY STAFF, EVOLVE AND EXECUTE THE GCP QUALITY STRATEGY AND RELATED OVERSIGHT ACTIVITIES SUPPORTING MOONLAKE’S CLINICAL PROGRAMS UP TO AND INCLUDING PHASE 3 AND INTO COMMERCIAL OPERATION.

Key accountabilities:

• As part of the MoonLake Quality Team, in consultation with the Associate VP Quality, The Quality Team, Key stakeholders, and using available resources:
• Identify and implement GCP Quality oversight requirements within MoonLake and our vendors.
• Define and implement MoonLake GCP Quality strategy in alignment with the key internal stakeholders and ensuring the legal standards. Define the strategy to provide the necessary oversight.
• Identify necessary resources to execute the plan, including recruitment of new team members and appropriate external resources (e.g. consultants).
• Lead the GCP Quality team as it executes the plan.
• Ensure that senior management are kept informed of progress, highlighting successes as well as potential issues.
• Working with the broader Quality Team, provide input to the development of the MoonLake Quality Systems, ensuring they meet GCP requirements relevant to the phase of development.
• Proactively provide GCP QA leadership across clinical programmes and MoonLake business activities.
• Lead, develop and line management of GCP team, assigning Quality Representatives for clinical programmes, and escalation point for GCP issues on clinical studies.
• Provide training, expertise and guidance to staff on regulatory GCP compliance matters and continuous quality improvement initiatives.
• Delegate for the Associate VP Quality, as necessary.
• Maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the Company.

SKILLS/KNOWLEDGE/BEHAVIOURAL COMPETENCIES:

• Demonstrates an in-depth knowledge of GCP and GCLP and related industry/regulatory guidelines governing clinical trials in the EU & USA as applied to late-stage product development and licensure.
• Some knowledge of other GxPs, including GMP, as applied to clinical development would be an advantage.
• Critical thinking, risk management and risk-based mindset.
• A Team leader, not just a manager.
• Ability to clearly communicate with members of staff at all levels throughout the organization, up to and including executive level.
• Ability to negotiate, manage conflicts and influence others at all levels, internally and externally, on a day-to-day basis.
• Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external entities including CROs and consultants.
• Highly organised self-motivator, able to prioritise activities, work well under pressure and meet deadlines.
• Highly developed decision-making skills, including dealing with ambiguity when reaching decisions.
• Ability to find pragmatic solutions for quality issues in a highly agile biotech environment.

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.

ABOUT US

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.
We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.
Further information is available at www.moonlaketx.com