Director, Quality Technical Operations

About the role

We are seeking a Director of Quality Technical Operations to lead a high-impact Quality function spanning QA MES, QA Validation Oversight, and QA Tech Transfer. You will define and implement cGMP best practices, set quality standards and metrics, and ensure clinical and commercial manufacturing operations meet and exceed regulatory compliance requirements.

Responsibilities

• Define and implement quality standards, systems, and metrics across clinical and commercial manufacturing operations.
• Provide quality oversight to activities related to validation and ensure that they are effectively administered and comply with regulatory requirements.
• Oversee QA tasks related to electronic manufacturing record management and tech transfer.
• Compile, organize, and present quality metrics and trends to senior leadership.
• Plan and allocate QA resources to meet program goals, timelines, and priorities.
• Coordinate prioritization of activities with area management to optimize execution.
• Prepare for regulatory and customer audits; ensure observations are addressed effectively and on schedule.
• Maintain safety and operational standards and approve documents related to QA functions.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or related field, or equivalent combination of education and experience.
• 12+ years of relevant work experience for a Director level, or 15+ years for a Senior Director level.
• Proven leadership in cGMP environments with hands-on experience in QA systems and metrics.
• A track record of successful audit readiness, execution, and response management.
• Strong collaboration, communication, and stakeholder engagement skills.
• An understanding of bulk API biologics manufacturing operations.

Pay

Salary Range (annually) $172,200.00 - $338,400.00

Schedule

Location: Rensselaer, NY, Work model: Monday-Friday, 8am-4:30pm

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.