Director, Quality Technical Operations

Director Of Quality Technical Operations

Regeneron is hiring! As the Director of Quality Technical Operations you will lead a high-impact Quality function spanning QA MES, QA Validation Oversight, and QA Tech Transfer. You'll define and implement cGMP best practices, set quality standards and metrics, and ensure clinical and commercial manufacturing operations meet and exceed regulatory compliance requirements.

In this role, a typical day might include the following:

• 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.

This role might be for you if you have:

• 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.

To be considered for this role you must hold a Bachelor's degree in Life Sciences or related field and the following amount of relevant pharmaceutical manufacturing experience for each level:

• Director – 12+ years
• Sr Director – 15+ years

Level to be determined based on qualifications relevant to the role. May substitute proven experience for education requirement.