Manager Quality Risk Management

Regeneron Pharmaceuticals • Saratoga Springs, UT

4d • $92,200 - $176,000 • 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 in Saratoga Springs. 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 regulatory and accrediting agencies. The position also supports departments and project teams in achieving quality and business objectives related to GxP risk management.

The position collaborates across IOPS to identify risk-based tools and methodologies for local and global efficiency and compliance improvements; establishes risk management principles, methods, tools, and documentation; and serves as a QRM subject matter expert and resource. It leads data-driven risk assessments, oversees the QRM program and assessment schedule, communicates assessment outcomes and periodic site-wide reviews, and works with the QRM Management team to integrate risk management into the Quality System. The role manages and develops a team, maintains risk documentation, supports new assessments, and represents Regeneron’s QRM approach during regulatory inspections and partner audits.

The initial location is Rensselaer, New York, with a permanent location in Saratoga Springs, New York. The stated work model is Monday through Friday, 8:00 a.m. to 4:30 p.m. The posting notes that many Regeneron roles are required to be performed on-site and advises candidates to confirm expectations with their recruiter and hiring manager.

Requirements

• Bachelor’s degree 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; the posting also lists 6 or more years for the Associate Manager level. Level will be determined based on experience.
• 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 improvements locally and globally.
• Formulate risk management principles, methods, and tools, and document them in appropriate policies, procedures, and reports.
• Educate and train staff across sites in quality risk management principles and practices, and serve as a QRM subject matter expert and resource.
• 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 occur at required frequencies, and manage the process, tasks, and communications.
• Communicate the outcomes of 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 IOPS risk assessments.
• Represent Regeneron’s QRM approach during regulatory inspections and partner audits.
• Represent the QRM team as a subject matter expert in risk management governance processes.

Benefits

• Annual bonuses or other incentive plans may be included, depending on country and role.
• Equity awards may be included, depending on country and role.
• Pension or retirement benefits may be included, depending on country and role.
• 401(k) company match may be included, depending on country and role.
• Health and wellness programs may be included, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits may include medical, dental, vision, life, and disability coverage.
• Paid time off may be included, depending on country and role.
• Family support benefits may be included, depending on country and role.

What This Job Offers

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