Kardigan
Senior Director, Head of GxP Compliance
South San Francisco, California, United States, Princeton, New Jersey, United States. Posted 12 days ago
The role
The Head of GxP Compliance will oversee the development, implementation, and management of GxP compliance activities. This includes managing audits, inspection readiness, and regulatory surveillance to support the company's growth toward becoming a global commercial-stage biopharmaceutical company.
What you will do
- Provide direction and planning for build out of the GxP Compliance team
- Establish and iteratively improve GxP Compliance processes and systems
- Develop and execute annual risk-based internal and external audit schedule across all GxP areas
- Manage external audits from regulatory agencies and other stakeholders
- Develop training programs for GxP compliance
- Ensure organization is prepared for regulatory inspections through readiness programs and mock inspections
- Establish processes for regulatory surveillance
- Coordinate external engagement activities in key industry forums
- Direct the development and maintenance of GxP compliance documentation, processes and metrics
- Prepare regular reports for management review and senior leadership
Required qualifications
- Bachelor’s degree in a life science or healthcare field
- Minimum of 10 years of experience in GxP Compliance, quality assurance and/or clinical operations within the pharma/biotech industry
- Proven track record establishing and developing high performing teams, including strong experience with people management and talent development
- Strong knowledge of FDA/EU/ICH requirements across GxP areas
- Experience in leading regulatory inspections (running front and back rooms) and setting up inspection readiness programs
- Proven track record of establishing excellent relationships and partnerships within Quality and across Development and Technical Operations
- Able to apply a risk-based analysis to quality and compliance issues
- Able to collaborate and communicate well with all levels of employees, including peers, executives and cross-functionally
Nice to have
- Advanced degree in a life science or healthcare field
- Experience in all clinical phases through commercialization
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. The company has a cutting-edge discovery and translational research platform and a pipeline of late-stage candidates.