Director Quality GCP

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 Moon Lake’s clinical programs up to and including Phase 3 and into commercial operation.
Key accountabilities:

• As part of the Moon Lake 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 Moon Lake and our vendors.
  • Define and implement Moon Lake 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 Moon Lake Quality Systems, ensuring they meet GCP requirements relevant to the phase of development.
• Proactively provide GCP QA leadership across clinical programmes and Moon Lake 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.

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…