Quality & Regulatory Lead

Our 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.

Job Title: Quality & Regulatory Lead

Location: New York, NY

What'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.

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells.

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells –creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.