The Manager Quality (GCP) ensures robust GCP compliance and quality oversight across MoonLake´s clinical development programmes by serving as a quality expert, leading and supporting audits, managing quality risks, and supporting inspections readiness. The role provides operational quality support to clinical teams and vendors to ensure trials are conducted to the highest regulatory standards
Key Accountabilities:- GCP Quality Oversight & Clinical Trial Support: Support implementation and delivery of GCP Quality oversight requirements within MoonLake and our vendors. Provide quality guidance to assigned clinical trial teams (acting as sponsor Study GCP Quality Lead). Attend internal clinical meetings and provide Quality representation on assigned clinical trials. Collaborate and share information within GCP team to ensure ongoing oversight of all GCP activities within and subcontracted by Moonlake. Ensure proactive oversight of quality risk management processes in assigned clinical programme/trials, including quality risk assessments and management to ensure clinical programmes are always complying and inspection ready.
- Quality Issues, CAPA & Risk Management: Act as Study GCP Quality lead for Quality issues, CAPAs, and CAPA effectiveness checks for assigned clinical programmes/trials and working with Owners and counterpart CRO leads to resolution.
- Audits, Inspections & Vendor Oversight: Conduct (as Lead or Support auditor depending on areas of expertise) assigned internal and external (vendor) GCP and/or GCLP audits. Conduct vendor qualifications and QA assessments. Support GCP inspection readiness activities and management of regulatory inspections of MoonLake (e.g. mock inspection activities and backroom activities, etc.).
- Quality Systems & Documentation: As a member of the MoonLake Quality Team, maintain and monitor the GxP Quality Management System (QMS). Ensuring that the QMS meets all necessary regulatory requirements, including good practice guidelines and standards, with specific emphasis on GCP compliance. To maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the Company.
- Performance Monitoring & Quality Metrics: Maintain agreed quality metrics and dashboards to enable clear communication to senior management and clinical study teams of compliance performance and any risks or issues identified. To provide support and advice to clinical study teams with regards to management of quality issues, CAPAs and changes.
- Reporting & Governance: Ensure that Director, GCP is kept informed of progress, highlighting successes as well as potential issues on clinical programmes or Moonlake Quality management system activities.