Director Quality Assurance, Drug Substance Manufacturing

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director of Quality Assurance to provide quality leadership for the startup and long-term operations of the Regeneron Drug Substance manufacturing facility located in Saratoga Springs NY, a greenfield biologics site scheduled to begin operations in 2028.  The position is responsible for building the QA organization and digital processes needed to support facility design, commissioning, qualification, and startup, and for the ongoing QA oversight of a fully automated “plant of the future” built around high levels of technology integration, data integrity, and review-by-exception batch disposition.  The director will define the quality process, automation and data requirements needed to enable review by exception and will provide leadership and direction across cell culture, centrifugation, chromatography, UFDF, and aseptic dispensing operations, ensuring compliance with current FDA and International Regulatory Body requirements.

When & where:

• Location: Saratoga Springs, NY and Rensselaer, NY

• Work model: Monday-Friday, 8am-4:30pm

Discover your role:

• Lead the QA startup strategy for the Saratoga Drug Substance facility, including quality systems build-out, staffing, and readiness for design review, commissioning, qualification, and process validation

• Define the automation, systems integration, and data integrity requirements (e.g., MES, DCS/SCADA, historian, LIMS) needed to enable review-by-exception batch record disposition

• Partner with Automation, Engineering, and IT/Data Integrity functions to design exception-based quality control strategies, including electronic batch record rules, automated in-process checks, and real-time release criteria

• Build and execute a business strategy that translates vision and corporate goals into departmental objectives for a highly automated plant of the future

• Builds and maintains a high performing team of managers, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments. Sets the course for the future- defines priorities, goals and objectives for quality team

• Provide direction, set performance standards, evaluate, develop performance and inspire direct reports

• Drives departments for optimal performance and constantly raises the bar, accountable for the performance and results of a department

• Ensure manufacturing quality staff are appropriately trained to support a highly automated, review-by-exception environment. Responsibilities include exception review, in-process testing oversight, batch record review, and quality-on-the-shop-floor responsibilities of first response to product quality issues in production

• Provide career development and training advice.  Provide regular feedback to direct reports on company and departmental operations

• Establishes data integrity governance for automated systems, ensuring ALCOA+ principles and 21 CFR Part 11/Annex 11 compliance are designed into the facility from startup

• Directs the activities of resources, both internal and outside contractors/vendors/systems integrators, with similar technical or functional responsibilities supporting facility digital startup and automation design

• Lead cross functional teams and manages the deliverables for the assigned projects.  Drives projects through completion within timeline, quality and budgetary constraints.  Interfaces with senior management to report on project and program milestones and to present project needs

• Accountable for ensuring policies, procedures, and standards are established, consistently followed, and adhered to on a consistent basis; develops new quality systems appropriate for a fully automated facility

• Provides first response for Quality and Compliance issues on the manufacturing floor.

• Provides review and final QA approval of deviations, and other quality events; protocols/reports; change documentation, SOPs; master batch record approval, including automation/system-based release logic

• Ensures product, facility, and equipment holds are placed when batch, equipment or system integrity is questioned

• Responsible for representing the Company and directly interfacing with auditors during regulatory body inspections, including inspections of automation and data integrity systems

• Ensures periodic informal audits are completed in production

• Leads teams for tracking of quality activities, metrics, CAPA tracking, etc