Manager Quality Risk Management

Regeneron Pharmaceuticals • Saratoga Springs, NY

3d • Onsite

About The Position

Regeneron is hiring a Manager Quality Risk Management (QRM) to join its team at a highly automated drug substance manufacturing facility. The role leads implementation of the QRM Governance process globally across Regeneron Industrial Operations & Product Supply (IOPS) sites, ensuring compliance with applicable global regulations and standards established by governing regulatory and accrediting agencies. The manager also supports departments and project teams in meeting quality and business objectives related to GxP risk management.

The initial work location is Rensselaer, New York, with the permanent location in Saratoga Springs, New York. The stated schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m. Level may be determined based on experience.

Requirements

• BS/BA in Biological Sciences, Chemistry, Biochemistry, or a related field, or an equivalent combination of education and experience.
• At least 7 years of experience for the Manager Quality Risk Management level.
• Previous people leadership or supervisory experience.
• Experience with recombinant protein manufacturing or development of manufacturing processes.

Responsibilities

• Work across IOPS departments to identify risk-based tools and methodologies that support efficiency and compliance-related improvements at local and global levels.
• Formulate risk management principles, methods, tools, and documents for inclusion in Regeneron policies, procedures, and reports.
• Educate and train staff across sites in quality risk management principles and practices, and serve as a subject matter expert and resource for QRM matters.
• Lead data-driven risk assessments, including risk identification, analysis, and ranking.
• Collaborate with and educate cross-functional team members on applying and complying with risk assessment and mitigation processes.
• Implement the QRM program, ensure risk assessments are conducted at required frequencies, and manage related processes, tasks, and communications.
• Communicate outcomes from quality risk management activities and periodic site-wide reviews.
• Work with the QRM Management team to integrate quality risk management concepts and philosophies into the overall Quality System.
• Develop, coach, and support direct reports and the broader team to build a sustainable QRM organization.
• Manage a team responsible for maintaining risk documents and supporting new risk assessments for IOPS.
• Represent Regeneron’s approach to QRM during regulatory inspections and partner audits.
• Represent the QRM team as a subject matter expert in risk management governance processes.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager