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Sr. Director, Head of GxP Compliance

South San Francisco, California, United States, Princeton, New Jersey, United States

About Us 

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 is our mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. 

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.   

These values are the foundation of our work, empowering us to make a real difference, every day.  

 

Kardigan is seeking a Sr. Director, 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 management, issue escalation, 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 and is a 4 day on-site required position.   

It can be located in San Francisco, CA or Princeton, NJ

 

Key Responsibilities:

  • Design and build a 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 key stakeholders, the establishment and iterative improvement of GxP Compliance processes and systems, including:
    • Audit program: develop and execute annual risk-based internal and external audit schedule; 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
    • Issue escalation and management: establish processes and procedures to ensure that issues are appropriately escalated, communicated and managed through resolution, including corrective and preventive actions
    • External monitoring and engagement: 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
    • Documentation and reporting: direct the development and maintenance of GxP compliance documentation (policies, procedures, records); prepare regular reports for senior leadership on compliance status
  • Contribute to cross-functional and enterprise level initiatives, for example:
    • Risk management: support the establishment of practices related to quality risk management and enterprise level risk and compliance reporting
    • Quality Management System: support the establishment and continuous improvement of the Kardigan QMS by mapping regulations to SOPs and identifying updates as guidance and requirements evolve
  • 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

 

 

Here’s What You’ll Bring to the Table:

  • Bachelor’s degree in a life science or healthcare field; advanced degree preferred
  • Minimum of 10 years of experience in GxP Compliance, quality assurance or regulatory affairs within the pharma/biotech industry; ideally in all clinical phases through commercialization
  • 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 with R&D and Technical Operations organizations 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 will with all levels of employees, including peers, executives and cross-functionally

 

 

 

 

 

 

Exact Compensation may vary based on skills, experience and location.

Pay range

$244,000 - $318,000 USD

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