Director Quality GCP

Job Purpose

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.

Your profile

Education:

• Bachelor’s degree in life science or healthcare field required. Advanced degree or equivalent education/degree in life sciences/healthcare preferred (PhD/MD/ PharmD/ Masters)

• Comprehensive (10+ years) experience working in Clinical Quality Assurance and expert knowledge of Good Clinical Practice (GCP) requirements across all phases of clinical development, including marketing authorization application activities.
• Strong familiarity and knowledge of GCP requirements in USA, EU, UK and experience with providing clinical GCP/Quality Assurance expertise on global clinical trials.
• Leading GCP inspection readiness activities and hosting regulatory GCP inspections (FDA, MHRA, EMA).
• Implementing and delivering risk-based clinical audit programmes.
• Establishing risk assessment methods in monitoring of relevant indicators/metrics/thresholds to ensure the detection of potential issues, early signals or trends of risks at clinical study or programme level.
• Strong experience in project management and leading on Quality initiatives to success.
• Proven track record leading a team within a dynamic agile and fast-paced organisation.
• Proven track record of monitoring and influencing the quality performance of internal functions and contracted service providers, including internal and external audit experience in GCP risk-based GCP audit planning, conduct and reporting (study audits, internal and external audits, inspection readiness audits, end-to-end clinical trial system/process audits, etc.).
• Line management experience (2+ direct reports desirable)

• 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.

• 2 days a week in our brand new office in Porto or Cambridge with some travel
  

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 groundbreaking 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.