Senior Director, Head of GxP Compliance

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