Senior Director, Head of GxP Compliance
About The Position
Kardigan is seeking a Head of GxP Compliance to support its growth toward becoming a global, multi-product commercial-stage biopharmaceutical company. The role oversees the development, implementation, and management of GxP compliance activities, including audits, inspection readiness and management, regulatory surveillance, and other compliance programs. It is responsible for maintaining regulatory compliance, fostering a culture of quality, and ensuring that products and clinical trial activities comply with applicable regulations. The position reports to the Chief Quality Officer and is preferably based in Princeton, NJ, or South San Francisco, CA. The role will plan the buildout of the GxP Compliance team and work with Quality stakeholders to establish and continually improve audit, inspection-readiness, external-monitoring, documentation, process, and reporting systems. It will contribute to enterprise compliance governance and quality management system improvement, promote a quality and compliance mindset, and represent Kardigan in external forums. Other functional, company-wide, or industry-related activities may be assigned.
Requirements
- Bachelor’s degree in a life science or healthcare field.
- At least 10 years of experience in GxP Compliance, quality assurance, and/or clinical operations within the pharmaceutical or biotechnology industry.
- Proven track record establishing and developing high-performing teams, including people management and talent development.
- Strong knowledge of FDA, EU, and ICH requirements across GxP areas, and ability to assess compliance with regulations and industry expectations, including phase-appropriate controls and readiness.
- Experience leading regulatory inspections, including running front and back rooms, and establishing inspection-readiness programs.
- Proven ability to establish strong relationships and partnerships within Quality and across Development and Technical Operations to proactively integrate quality and compliance into standard practices and mindsets.
- Ability to apply risk-based analysis to quality and compliance issues and develop creative, flexible solutions that satisfy business requirements and legal obligations.
- Ability to collaborate and communicate effectively with employees at all levels, including peers, executives, and cross-functional colleagues.
Nice To Haves
- Advanced degree in a life science or healthcare field.
- Experience across all clinical phases through commercialization.
Responsibilities
- Provide direction and planning for building the GxP Compliance team in alignment with business objectives, ensuring appropriate staffing and capabilities through development and commercialization.
- Lead, with Quality stakeholders, the establishment and iterative improvement of GxP compliance processes and systems.
- Develop and execute an annual risk-based internal and external audit schedule across GCP, GLP, GDP/GMP, and GVP; manage regulatory agency and other stakeholder audits, coordinate responses and follow-up, analyze findings, and drive continuous improvement.
- Develop GxP compliance training programs and inspection-readiness programs, conduct mock inspections, and establish tools and processes for on-site and remote inspection management.
- Establish regulatory surveillance processes with cross-functional stakeholders and coordinate external engagement activities in key industry forums.
- Direct the development and maintenance of GxP compliance documentation, processes, and metrics, and prepare regular compliance reports for management review and senior leadership.
- Support enterprise-level compliance practices in conjunction with Legal.
- Support continuous improvement of the Kardigan Quality Management System by providing regulatory intelligence and audit insights.
- Promote a culture of quality, compliance, continuous improvement, and cross-functional problem-solving.
- Represent the company in external forums to advocate company positions and facilitate adoption of evolving expectations and state-of-the-art practices.
- Perform other functional, company-wide, or industry-related activities or projects as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
