Director, Global GxP Regulatory Intelligence (Remote)

Job Description

The Director Global GxP Regulatory Intelligence provides strategic leadership and quality oversight of the Global GxP Regulatory Intelligence, Regulatory Surveillance, and Compliance / Market Intelligence across all modalities (small molecule, biologics and devices/combo devices) as well as cross-GxP areas (GMP, GCP, GDP, GVP, GLP). This role is recognized as a leader in the organization and an expert in the principles and application of quality and regulatory compliance. This position within the Quality Organization is vital to the advancement of excellence in navigating the changing regulatory landscape as well as understanding the requirements as Vertex moves into new global markets. The role is accountable for maintaining robustness of existing processes as well as developing innovative approaches to ensure continuous quality improvement. This role requires strong leadership skills, extensive people management skills, the ability to operate in a matrix organization as well as and the ability to be independent and autonomous. This role requires expert technical skills and demonstrated experience and capabilities in navigating regulatory requirements, assessing the Quality Management System for gaps and effectively implementing solutions and processes to close those gaps.

Position may require up to 10% domestic/international travel.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Drives continuous improvement in Vertex quality processes and governance through the surveillance process evaluation to ensure Vertex remains adherent to evolving regulatory expectations and supports QA operational quality oversight and a comprehensive Quality Management System (QMS)

• Accountable for developing and implementing strategies to translate Regulatory Intelligence gathering into action plans for all GxP regulations globally as Vertex’s clinical and commercial strategies continues to evolve.

• Collaborates with the cross functional areas, including but not limited to GxP Compliance, QA Operations, International QA, Local Market Quality, Clinical Operations, Regulatory and Inspection Readiness teams to drive activities that ensure appropriate regulatory intelligence and compliance information is obtained, evaluated and actioned.

• Ensure robust monitoring and assessment all sources of Global GxP Regulatory Intelligence information for relevance and impact to Vertex processes. This includes:

  • Draft guidance documents

  • Modified or newly implemented regulations

  • Intelligence for new markets/regions

  • Evaluation and remediation of QMS gaps for new modalities as new programs are introduced to the pipeline

  • Compliance risk determination and reporting

• Accountable to analyze guidance and regulations from regulatory authorities and trade organizations and work cross-functionally to assess impact

• Identify and escalate potential risks and opportunities arising from regulatory landscape changes

• Project manage all gap assessments associated with Regulatory Intelligence to mitigate risks and prepare for launches in new markets as well as advance programs to comply to new standards and regulations

• Prepare comprehensive summaries, dashboards and robust project plans for communication with internal stakeholders and Sr. Leadership

• Establish and maintain robust systems to effectively monitor, analyze and implement global regulatory expectations

• Establish cross-functional working groups across QA and functional areas in Clinical, Regulatory and manufacturing, including SMEs, to facilitate review and assessment of Regulatory Intelligence to identify action plans, gaps and risks

• Drive external engagement by collaborating with industry organizations, committees, and/or forums to help shape regulatory environments and expectations.

Minimum qualifications:

• Demonstrated depth and breadth of global regulatory agency knowledge and GxP experience with current knowledge of industry trends and best practices for quality, efficiency, compliance and effectiveness

• Demonstrated working knowledge and practical application of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) in an operational setting including US and international/global regulatory requirements and associated guidances and standards (e.g. ISO, ICH, USP, etc.)

• Knowledge of Regulatory Intelligence framework

• Strong leadership skills with ability to set strategic vision for the function, thrive in a fast-paced environment, and act with urgency.

• Strong problem solvin