Director – GMP/GDP Regulatory Surveillance

Director – GMP/GDP Regulatory Surveillance

Requirements

• 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 application of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) including US and international/global regulatory requirements and associated guidances and standards (e.g. ISO, ICH, USP, etc.)
• Knowledge of Regulatory Intelligence tools
• Strong leadership skills with the ability to thrive in a fast-paced environment and act with urgency
• Strong problem solving and critical thinking skills, accompanied by analytical thinking/data analysis skills required to make sound decisions
• Demonstrated strategic planning and execution skills required
• Ability to monitor trends, detect shifts in requirements and implement strategies for compliance
• Current knowledge of industry trends and best practices for progressive quality management in a regulated environment
• Proven leadership capabilities within a multi-level organization to support development of individuals and teams
• Creative, innovative leadership experience with strong change management experience, adaptability and resourcefulness
• Excellent communication skills and a proven track record influencing/building/promoting a culture of Quality and Excellence
• Project Management / Continuous Improvement: Ability to lead and manage complex projects/teams with corporate objectives and project timelines; Proficiency utilizing project management processes / tools to lead meetings, project planning and facilitating completion key deliverables
• Cross-functional Collaboration: Ability to drive results, work collectively with stakeholders and maintain composure under pressure
• Communication/Coaching / Influencing: Ability to communicate effectively across all organizational levels; Presentation/Facilitation skills—ability to adjust presentation to audience and information real-time; Ability to effectively influence others within technical area of expertise; Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff
• Strong oral and written communication and interpersonal skills
• Excellent technical writing skills

Responsibilities

• Drives continuous improvement in Vertex quality processes and governance to ensure Vertex remains adherent to 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 GMP/GDP regulations globally
• Collaborates with the CMC Compliance, QA Operations, International QA, Regulatory and Inspection Readiness teams to drive activities that ensure appropriate regulatory intelligence and compliance information is obtained, evaluated and actioned
• Monitors and assesses all sources of global GMP/GDP intelligence information for relevance and impact to Vertex processes
• 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/Surveillance 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, including SMEs, to facilitate review and assessment of regulatory intelligence to identify action plans, gaps and risks
• Develop and implement strategies to ensure compliance with emerging regulations and regulations associated with new markets

Preferred Qualifications

No preferred qualifications provided.