Executive Director, QA Sterility Assurance

About this role

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director, QA Sterility Assurance who leads the strategy, design, and operational execution of Regeneron's GMP contamination control program across aseptic and low-bioburden biopharmaceutical manufacturing operations. This individual provides technical and operational direction to ensure robust environmental control, sterility assurance, and microbial contamination risk management across the network, driving compliance with global regulatory expectations for sterile and non-sterile product manufacturing. This position guides functional areas in support of compliance and business objectives, ensures the contamination control strategy remains current with evolving industry and regulatory expectations, and serves as the key liaison with operational microbiology and manufacturing subject matter experts across the lines of business.

When & where: • Location: East Greenbush, NY

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

Discover your role: • Design, implement, and continuously improve a holistic Contamination Control Strategy (CCS) grounded in sound microbiological science, aseptic processing principles, and applicable quality, regulatory, and legal requirements.

• Provide expert vision in environmental monitoring (EM) programs, cleanroom classification, personnel qualification, gowning practices, and aseptic process simulation (media fill) performance across manufacturing sites.

• Influence root cause investigations and risk assessments for microbial excursions, sterility failures, and environmental monitoring deviations, ensuring timely, science-based corrective and preventive actions.

• Monitor contamination control program performance using meaningful operational metrics (e.g., EM trends, excursion rates, media fill success rates) and demonstrate a commitment to continuous improvement.

• Embed quality risk management (QRM) tools—such as FMEA and contamination risk mapping—within microbiology and aseptic operations to proactively identify and mitigate contamination vectors.

• Maintain current expertise in evolving regulatory expectations (e.g., EU Annex 1, FDA Aseptic Processing Guidance, USP , PIC/S) and proactively integrate emerging requirements into the contamination control program.

• Apply quality and risk management tools to make timely, science-based decisions that protect patient safety and product sterility.

• Partner closely with QA Operations, Manufacturing, Facilities/Engineering, and Microbiology Lab functions to translate contamination control strategy into robust, compliant aseptic practices on the floor.

• Serve as the senior microbiological and contamination control decision-maker, exercising sound judgment under pressure to ensure product safety and efficacy.

• Represent Regeneron as the subject matter authority on contamination control and sterility assurance to internal leadership, regulatory agencies, and corporate/external partners.

• Translate contamination control vision and strategy into executable, resourced action plans across the manufacturing network.

• Ensure the Contamination Control Strategy is transparent, well-documented, and that the broader organization is engaged and accountable for its execution.

• Establish high standards for performance management and accountability to achieve microbiological, sterility assurance, and organizational objectives.

This role requires: • Bachelor’s degree in Microbiology, Molecular Biology, Biology, Pharmaceutical Sciences, or related scientific discipline (advanced degree preferred) , or equivalent combination of education and experience, and the following amount of progressive experience in pharmaceutical/biopharmaceutical microbiology, sterility assurance, or contamination control, including significant leadership experience in aseptic manufacturing environments, for each level: • Senior Director – 15+ years

• Executive Director – 18+ years

• Level will be determined based on experience

• Deep operational expertise in aseptic processing and low-bioburden manufacturing, including cleanroom design/classification, HVAC airflow principles, personnel and material flow, gowning qualification, and aseptic technique.

• Demonstrated hands-on ownership of a Contamination Control Strategy (CCS), including environmental monitoring program design, trending, and risk-based EM site selection.

• Strong working knowledge of aseptic process simulation (media fill) design, execution, and failure investigation.

• Expert-level understanding of global regulatory expectations and guidance, including EU Annex 1 (2022 revision), FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing, USP , PIC/S, and ISO 14644.

• Proven track record leading root cause investigations, deviation management, and CAPA for microbial contamination events, sterility test failures, and environmental excursions.

• Demonstrated ability to apply Quality Risk Management tools (FMEA, fishbone, risk mapping) to contamination control and microbiological decision-making.

• Experience representing microbiological/contamination control positions directly to health authorities during inspections (FDA, EMA, MHRA) with a strong inspection track record.

• Demonstrated success partnering cross-functionally with Manufacturing, Facilities/Engineering, QA Operations, and Microbiology Labs to translate strategy into floor-level execution.

• Strong people leadership experience, including building and developing high-performing technical teams and driving accountability across a matrixed organization.

• Excellent judgment and composure in high-stakes, time-sensitive decision-making affecting product disposition and patient safety.

• Executive presence and communication skills suited to representing the company with regulators, corporate partners, and senior leadership.

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