Bachelor's degree in a life science or healthcare field
Minimum of 10 years in GxP Compliance, quality assurance, or clinical operations in pharma/biotech
Proven experience in building and managing high-performing teams
Strong knowledge of FDA/EU/ICH GxP requirements
Experience leading regulatory inspections and establishing inspection readiness programs
Ability to foster relationships across Quality, Development, and Technical Operations
Skilled in risk-based analysis for quality and compliance issues
Responsibilities
Provide strategic direction for building the GxP Compliance team to align with business goals
Lead the development and improvement of GxP Compliance processes and systems
Develop and execute a risk-based audit schedule across all GxP areas
Establish inspection readiness programs and conduct mock inspections
Coordinate regulatory surveillance and external engagement activities
Direct the creation and maintenance of GxP compliance documentation and reporting
Promote a culture of quality and compliance across the organization
Benefits
Opportunity to shape the GxP Compliance function in a growing biopharmaceutical company
Collaborative work environment with cross-functional teams
Engagement in industry forums to influence best practices
Focus on continuous improvement and talent development
Flexibility to take on diverse projects and initiatives
Full Job Description
Location: Princeton, NJ (preferred) or South San Francisco, CA
Job Overview
Kardigan is seeking a Head of GxP Compliance to support the company's growth toward becoming a global, multi-product commercial-stage biopharmaceutical company. This position will be responsible for overseeing the development, implementation, and management of GxP compliance activities, including internal and external audits, inspection readiness and management, regulatory surveillance, and other compliance programs and initiatives as needed. This position will play a critical role in maintaining regulatory compliance, fostering a culture of quality, and ensuring that our products and clinical trial activities are compliant with applicable regulations. This position will report to the Chief Quality Officer.
Key Responsibilities:
Provide direction and planning for build out of the GxP Compliance team in alignment with business objectives to ensure that appropriate staffing and capabilities are in place to protect patient safety and product quality through phased development and commercialization
Lead, working in collaboration with Quality stakeholders, the establishment and iterative improvement of GxP Compliance processes and systems, including:
GxP Audit Program: develop and execute annual risk-based internal and external audit schedule across all GxP areas (GCP, GLP, GDP/GMP, GVP); manage external audits from regulatory agencies and other stakeholders, coordinating responses and follow-up actions; analyze audit findings to identify trends and drive continuous improvement
Inspection Readiness and Management: develop training programs for GxP compliance; ensure the organization is prepared for regulatory inspections by establishing inspection readiness programs and conducting mock inspections; establish tools and processes for on-site and remote inspection management
External Monitoring and Engagement: working with cross-functional stakeholders establish processes for regulatory surveillance to ensure the organization stays abreast of GxP regulatory requirements and trends; coordinate external engagement activities enabling Kardigan to have a "seat at the table" in key industry forums
GxP Compliance Processes and Reporting: direct the development and maintenance of GxP compliance documentation (policies, procedures, records), processes and metrics; prepare regular reports for management review and senior leadership on compliance status
Contribute to cross-functional and enterprise level initiatives, for example:
Compliance Governance: in conjunction with Legal, provide support for the establishment of enterprise level practices
Quality Management System: support continuous improvement of the Kardigan QMS by providing regulatory intelligence and audit insights
Promote a culture of quality and compliance mindset, continuous improvement and cross-functional problem-solving.
Represent company in external forums to advocate company positions and facilitate adoption of evolving expectations and state of the art practices
Maintain flexibility to perform other functional or company-wide or industry-related activities or projects as assigned
Basic 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. Ability to assess compliance to regulations and industry expectations, including phase appropriate controls and readiness
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 to proactively build quality and compliance into standard practices and mindsets
Able to apply a risk-based analysis to quality and compliance issues with a demonstrated creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations
Able to collaborate and communicate well with all levels of employees, including peers, executives and cross-functionally
Preferred Qualifications:
Advanced degree in a life science or healthcare field
Experience in all clinical phases through commercialization
Exact Compensation may vary based on skills, experience and location.
