Director, Clinical Quality Lead

The role

The Clinical Quality Lead manages GxP Quality Assurance functions and provides consultation on GxP regulations, guidelines, policies, and procedures. This role ensures compliance throughout the R&D process by collaborating with cross-functional teams to evaluate processes and activities.

What you will do

• Partners with Clinical Development/Operations to ensure GCP compliance.
• Reviews study-related documents and plans.
• Support and maintain the internal audit program, audit schedule, and approved vendor list.
• Performs internal and external audits to ensure compliance with GXP regulations and guidelines.
• Communicates audit results to internal stakeholders and writes audit reports.
• Supports Quality Management System including CAPAs, audits, inspections, deviation management, risk management, change control and quality complaint handling.
• Monitor, track, and trend GxP non-conformances, deviations, CAPAs.
• Leads or supports audit and inspection activities, including CAPA formulation, vendor assessments, and regulatory inspections.
• Maintains current regulatory inspection knowledge for regulatory agencies worldwide.
• Interprets global legislation, regulations and guidance for development or updates to policies and standards.

Required qualifications

• Bachelor’s degree in a scientific discipline
• 7+ years in a QMS environment with proven experience in discovery, as well as non-clinical and clinical development
• Direct experience with internal/external clinical systems and process audits
• Experience in QA audits of Clinical Investigator sites and clinical vendors
• Experience in the development of SOPs
• Knowledge and experience in Good Clinical Practices (GCP)
• Strong interpersonal, negotiation, and leadership skills
• Excellent written and verbal communication skills, with experience working in a culturally diverse, global team
• Ability to work independently and effectively prioritize tasks
• Expertise in Root Cause Analysis, CAPA development, and Risk Management methodology
• Insightful, decisive, proactive, and solutions-oriented
• Proven excellence in professional skills including communication, organization, prioritization, discretion, and accuracy

Nice to have

• 15+ years’ experience in the pharmaceutical or biotechnology industry with in-depth pharmaceutical QMS knowledge
• Knowledge and experience in Good Laboratory Practice (GLP, and/or Good Pharmacovigilance Practice (GVP) regulations

About the company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It has a cutting-edge discovery and translational research platform and a pipeline of late-stage candidates.