Quality & Regulatory Lead

Quality & Regulatory LeadOur client, a leading organization in the pharmaceutical and healthcare industry, is seeking a Quality & Regulatory Lead to join their team. As a Quality & Regulatory Lead, you will be part of the Regulatory Affairs department supporting global compliance and quality assurance initiatives. The ideal candidate will demonstrate strong leadership, meticulous attention to detail, and excellent communication skills, which will align successfully in the organization.Location: New York, NYWhat's the Job?Manage all product quality and compliance activities for a portfolio of external contract manufacturers and suppliers supporting Pfizer products and materials.Provide quality leadership and act as the regulatory expert within the Virtual Site Operating Teams (VSOT), advising on regulatory strategy and potential supply constraints.Assess supplier products, manufacturing processes, and documentation to ensure product specifications are met and quality systems are maintained.Support internal and external audit activities, including RQA audits and regulatory inspections, as applicable.Support compliance assessments to ensure ongoing GMP/GDP adherence and manage change controls to ensure timely completion of activities.What's Needed?Minimum of 5 years of experience in a GxP environment and/or Regulatory Affairs role.Relevant Master's degree required.Expertise in external supplier management, change management, and regulatory compliance.Strong knowledge of U.S., European, and global cGMP requirements, inspection trends, and quality assurance practices.Excellent communication skills with the ability to engage internal and external stakeholders clearly and diplomatically.What's in it for me?Opportunity to work in a dynamic and innovative environment focused on high-quality healthcare products.Engage in meaningful projects that impact global health and safety standards.Collaborate with a diverse and talented team committed to excellence and continuous improvement.Develop your professional skills through challenging assignments and ongoing learning opportunities.Be part of a company recognized for its commitment to diversity, inclusion, and ethical practices.